Heidi Splete

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

Use of metformin was associated with a significant reduction in the risk of developing basal cell carcinoma (BCC), based on data from a population case-control study in Iceland.

“In addition to general anticarcinogenic effects, metformin has also been shown to directly inhibit the sonic hedgehog pathway, a key pathway in basal cell carcinoma (BCC) pathogenesis,” Jonas A. Adalsteinsson, MD, of the University of Iceland, Reykjavik, and colleagues wrote. “The relationship between metformin and keratinocyte carcinoma has not been well-characterized but is of importance considering that metformin is a commonly prescribed medication.”

They added that the hedgehog pathway inhibitors vismodegib (Erivedge) and sonidegib (Odomzo), approved for treating BCC, “are highly effective for BCC prevention, but their broad use for BCC prophylaxis is limited due to numerous side effects.”

In the study, published in the Journal of the American Academy of Dermatology, the researchers identified 6,880 first-time cancer patients with BCC, squamous cell carcinoma in situ (SCCis), or invasive SCC, and 69,620 population controls using data from the Icelandic Cancer Registry and the Icelandic Prescription Medicine Register between 2003 and 2017. Metformin exposure was defined as having filled at least one prescription of metformin more than 2 years prior to cancer diagnosis. They used grams and daily dose units of metformin in their analysis; one DDU of metformin, “or its average daily maintenance dose when used for its primary indication, is 2 grams,” they noted.

Overall, metformin use was associated with a significantly lower risk of developing BCC, compared with nonuse (adjusted odds ratio, 0.71; 95% confidence interval, 0.61-0.83).

The reduced risk occurred similarly across age and gender subgroups, with the exception of individuals younger than 60 years, the researchers said. “This might signify that metformin has less of a protective effect in younger individuals, but we might also have lacked power in this category.” The association with reduced BCC risk remained significant at all three cumulative dose levels measured: 1-500 DDUs, 501-1,500 DDUs, and more than 1,500 DDUs.

Metformin use was not significantly associated with reduced risk of invasive SCC (aOR, 1.01) and in most cases of SCCis. However, the 501-1,500 DDU dose category was associated with a slight increase in risk of SCCis (aOR, 1.40; 95% CI, 1.00-1.96), “showing a possible increased risk of SCCis,” the authors wrote.

The decrease in BCC risk was seen across all metformin dosing levels, but the reason for this remains unclear, and might be related to a confounding factor that was not considered in this study, the researchers said. “It could also be that metformin’s BCC risk-lowering effect is immediate, with only a low dose being needed to see a clinical benefit.”

The study findings were limited by several factors, including the retrospective design and the inability to adjust for factors including ultraviolet exposure, Fitzpatrick skin type, and comorbidities. The frequent use of metformin by people with type 2 diabetes suggests diabetes itself or other diabetes medications could be possible confounding factors, the researchers wrote.

However, the results were strengthened by the large study population, and the data suggest an association between reduced risk of first-time BCC and metformin use, they added.

“Randomized, prospective trials are required to fully understand the effect metformin has on BCC and SCC risk,” the researchers concluded.

“There is a dire need to reduce incidence of skin cancers in general, and consequently a need for new non-surgical treatment options for keratinocytic nonmelanoma skin cancers,” Amor Khachemoune, MD, a dermatologist at the State University of New York, Brooklyn, and the department of dermatology of the Veteran Affairs NY Harbor Healthcare System, also in Brooklyn, said in an interview.

Dr. Khachemoune, who was not involved with the study, said that he was not surprised by the findings. “Like other well-studied sonic hedgehog inhibitors, vismodegib and sonidegib, metformin has a demonstrated effect on this pathway. The medical community outside of dermatology has extensive experience with the use of metformin for a host of other indications, including its role as anticarcinogenic, so it seemed natural that one would consider widening its use to quell the ever-expanding cases of basal cell carcinomas.”

However, complications from long-term use, though likely rare, could be a limitation in using metformin as a chemoprotective agent, Dr. Khachemoune said. Metformin-associated lactic acidosis is one example of a rare, but potentially life-threatening adverse event.

“Finding the right dosage and having an algorithm for follow up monitoring of side effects would certainly need to be put in place in a standardized way,” he emphasized. “As stated by the authors of this study, more inclusive research involving other groups with nonkeratinocytic malignancies in larger cohorts is needed.”

The study received no outside funding. The researchers and Dr. Khachemoune had no financial conflicts to disclose.

Use of metformin was associated with a significant reduction in the risk of developing basal cell carcinoma (BCC), based on data from a population case-control study in Iceland.

“In addition to general anticarcinogenic effects, metformin has also been shown to directly inhibit the sonic hedgehog pathway, a key pathway in basal cell carcinoma (BCC) pathogenesis,” Jonas A. Adalsteinsson, MD, of the University of Iceland, Reykjavik, and colleagues wrote. “The relationship between metformin and keratinocyte carcinoma has not been well-characterized but is of importance considering that metformin is a commonly prescribed medication.”

They added that the hedgehog pathway inhibitors vismodegib (Erivedge) and sonidegib (Odomzo), approved for treating BCC, “are highly effective for BCC prevention, but their broad use for BCC prophylaxis is limited due to numerous side effects.”

In the study, published in the Journal of the American Academy of Dermatology, the researchers identified 6,880 first-time cancer patients with BCC, squamous cell carcinoma in situ (SCCis), or invasive SCC, and 69,620 population controls using data from the Icelandic Cancer Registry and the Icelandic Prescription Medicine Register between 2003 and 2017. Metformin exposure was defined as having filled at least one prescription of metformin more than 2 years prior to cancer diagnosis. They used grams and daily dose units of metformin in their analysis; one DDU of metformin, “or its average daily maintenance dose when used for its primary indication, is 2 grams,” they noted.

Overall, metformin use was associated with a significantly lower risk of developing BCC, compared with nonuse (adjusted odds ratio, 0.71; 95% confidence interval, 0.61-0.83).

The reduced risk occurred similarly across age and gender subgroups, with the exception of individuals younger than 60 years, the researchers said. “This might signify that metformin has less of a protective effect in younger individuals, but we might also have lacked power in this category.” The association with reduced BCC risk remained significant at all three cumulative dose levels measured: 1-500 DDUs, 501-1,500 DDUs, and more than 1,500 DDUs.

Metformin use was not significantly associated with reduced risk of invasive SCC (aOR, 1.01) and in most cases of SCCis. However, the 501-1,500 DDU dose category was associated with a slight increase in risk of SCCis (aOR, 1.40; 95% CI, 1.00-1.96), “showing a possible increased risk of SCCis,” the authors wrote.

The decrease in BCC risk was seen across all metformin dosing levels, but the reason for this remains unclear, and might be related to a confounding factor that was not considered in this study, the researchers said. “It could also be that metformin’s BCC risk-lowering effect is immediate, with only a low dose being needed to see a clinical benefit.”

The study findings were limited by several factors, including the retrospective design and the inability to adjust for factors including ultraviolet exposure, Fitzpatrick skin type, and comorbidities. The frequent use of metformin by people with type 2 diabetes suggests diabetes itself or other diabetes medications could be possible confounding factors, the researchers wrote.

However, the results were strengthened by the large study population, and the data suggest an association between reduced risk of first-time BCC and metformin use, they added.

“Randomized, prospective trials are required to fully understand the effect metformin has on BCC and SCC risk,” the researchers concluded.

“There is a dire need to reduce incidence of skin cancers in general, and consequently a need for new non-surgical treatment options for keratinocytic nonmelanoma skin cancers,” Amor Khachemoune, MD, a dermatologist at the State University of New York, Brooklyn, and the department of dermatology of the Veteran Affairs NY Harbor Healthcare System, also in Brooklyn, said in an interview.

Dr. Khachemoune, who was not involved with the study, said that he was not surprised by the findings. “Like other well-studied sonic hedgehog inhibitors, vismodegib and sonidegib, metformin has a demonstrated effect on this pathway. The medical community outside of dermatology has extensive experience with the use of metformin for a host of other indications, including its role as anticarcinogenic, so it seemed natural that one would consider widening its use to quell the ever-expanding cases of basal cell carcinomas.”

However, complications from long-term use, though likely rare, could be a limitation in using metformin as a chemoprotective agent, Dr. Khachemoune said. Metformin-associated lactic acidosis is one example of a rare, but potentially life-threatening adverse event.

“Finding the right dosage and having an algorithm for follow up monitoring of side effects would certainly need to be put in place in a standardized way,” he emphasized. “As stated by the authors of this study, more inclusive research involving other groups with nonkeratinocytic malignancies in larger cohorts is needed.”

The study received no outside funding. The researchers and Dr. Khachemoune had no financial conflicts to disclose.

Use of metformin was associated with a significant reduction in the risk of developing basal cell carcinoma (BCC), based on data from a population case-control study in Iceland.

“In addition to general anticarcinogenic effects, metformin has also been shown to directly inhibit the sonic hedgehog pathway, a key pathway in basal cell carcinoma (BCC) pathogenesis,” Jonas A. Adalsteinsson, MD, of the University of Iceland, Reykjavik, and colleagues wrote. “The relationship between metformin and keratinocyte carcinoma has not been well-characterized but is of importance considering that metformin is a commonly prescribed medication.”

They added that the hedgehog pathway inhibitors vismodegib (Erivedge) and sonidegib (Odomzo), approved for treating BCC, “are highly effective for BCC prevention, but their broad use for BCC prophylaxis is limited due to numerous side effects.”

In the study, published in the Journal of the American Academy of Dermatology, the researchers identified 6,880 first-time cancer patients with BCC, squamous cell carcinoma in situ (SCCis), or invasive SCC, and 69,620 population controls using data from the Icelandic Cancer Registry and the Icelandic Prescription Medicine Register between 2003 and 2017. Metformin exposure was defined as having filled at least one prescription of metformin more than 2 years prior to cancer diagnosis. They used grams and daily dose units of metformin in their analysis; one DDU of metformin, “or its average daily maintenance dose when used for its primary indication, is 2 grams,” they noted.

Overall, metformin use was associated with a significantly lower risk of developing BCC, compared with nonuse (adjusted odds ratio, 0.71; 95% confidence interval, 0.61-0.83).

The reduced risk occurred similarly across age and gender subgroups, with the exception of individuals younger than 60 years, the researchers said. “This might signify that metformin has less of a protective effect in younger individuals, but we might also have lacked power in this category.” The association with reduced BCC risk remained significant at all three cumulative dose levels measured: 1-500 DDUs, 501-1,500 DDUs, and more than 1,500 DDUs.

Metformin use was not significantly associated with reduced risk of invasive SCC (aOR, 1.01) and in most cases of SCCis. However, the 501-1,500 DDU dose category was associated with a slight increase in risk of SCCis (aOR, 1.40; 95% CI, 1.00-1.96), “showing a possible increased risk of SCCis,” the authors wrote.

The decrease in BCC risk was seen across all metformin dosing levels, but the reason for this remains unclear, and might be related to a confounding factor that was not considered in this study, the researchers said. “It could also be that metformin’s BCC risk-lowering effect is immediate, with only a low dose being needed to see a clinical benefit.”

The study findings were limited by several factors, including the retrospective design and the inability to adjust for factors including ultraviolet exposure, Fitzpatrick skin type, and comorbidities. The frequent use of metformin by people with type 2 diabetes suggests diabetes itself or other diabetes medications could be possible confounding factors, the researchers wrote.

However, the results were strengthened by the large study population, and the data suggest an association between reduced risk of first-time BCC and metformin use, they added.

“Randomized, prospective trials are required to fully understand the effect metformin has on BCC and SCC risk,” the researchers concluded.

“There is a dire need to reduce incidence of skin cancers in general, and consequently a need for new non-surgical treatment options for keratinocytic nonmelanoma skin cancers,” Amor Khachemoune, MD, a dermatologist at the State University of New York, Brooklyn, and the department of dermatology of the Veteran Affairs NY Harbor Healthcare System, also in Brooklyn, said in an interview.

Dr. Khachemoune, who was not involved with the study, said that he was not surprised by the findings. “Like other well-studied sonic hedgehog inhibitors, vismodegib and sonidegib, metformin has a demonstrated effect on this pathway. The medical community outside of dermatology has extensive experience with the use of metformin for a host of other indications, including its role as anticarcinogenic, so it seemed natural that one would consider widening its use to quell the ever-expanding cases of basal cell carcinomas.”

However, complications from long-term use, though likely rare, could be a limitation in using metformin as a chemoprotective agent, Dr. Khachemoune said. Metformin-associated lactic acidosis is one example of a rare, but potentially life-threatening adverse event.

“Finding the right dosage and having an algorithm for follow up monitoring of side effects would certainly need to be put in place in a standardized way,” he emphasized. “As stated by the authors of this study, more inclusive research involving other groups with nonkeratinocytic malignancies in larger cohorts is needed.”

The study received no outside funding. The researchers and Dr. Khachemoune had no financial conflicts to disclose.

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Different kinds of neuropsychiatric (NP) events in patients with systemic lupus erythematosus (SLE) have substantial variability in their occurrence, resolution, and recurrence over time, as well as in their predictors, according to new research from a large, prospective, international, inception cohort study.

Because “multiple NP events due to different causes may present concurrently in individual patients, the findings emphasize the importance of recognizing attribution of NP events as a determinant of clinical outcome,” John G. Hanly, MD, of Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, N.S., and colleagues wrote in Arthritis & Rheumatology.

In a previous study of the same group of 1,827 patients with SLE, NP events occurred in about half and approximately one-third of these events were deemed disease related. They also “occurred most frequently around the diagnosis of SLE and had a significant negative impact on health-related quality of life,” the researchers wrote.

Researchers involved with the Systemic Lupus International Collaborating Clinics recruited the 1,827 adults with SLE over an 11-year period during 1999-2011 from a total of 31 sites in Europe, Asia, and North America. The average age of the patients at study enrollment was 35 years, 89% were women, and 49% were White. The mean disease duration was 5.6 months, and 70% of patients were taking corticosteroids at enrollment.

Over an average follow-up period of 7.6 years, 955 patients (52.3%) experienced a single neuropsychiatric event, and 493 (27.0%) experienced two or more events; the total number of unique NP events was 1,910. Most of these unique events (92%) involved the central nervous system, and 8.4% involved the peripheral nervous system.

The researchers used multistate models to attribute NP events to SLE based on factors that included the temporal onset of NP events in relation to SLE diagnosis, concurrent non-SLE factors, and NP events that are common in healthy controls. The four states in the multistate models were no NP events, no current NP event but a history of at least one event, new or ongoing NP events, and death. The results included a multivariate analysis of a model involving 492 observed transitions into new or ongoing NP events.

In the multivariate analysis, factors positively associated with SLE-attributed NP events included male sex (hazard ratio, 1.35; P = .028), concurrent non-SLE NP events excluding headache (HR, 1.83; P < .001), active SLE based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (HR, 1.19; P = .012), and corticosteroid use (HR, 1.59; P = .008). The researchers also found that SLE-attributed NP events were negatively associated with Asian race/ethnicity, postsecondary education, and use of immunosuppressive drugs.

Another multivariate analysis found that non-SLE NP events were positively associated with only concurrent SLE-attributed NP events excluding headache (HR, 2.31; P < .001), but negative associations were seen with non-U.S. African race/ethnicity and Asian race/ethnicity.

The researchers found that SLE-attributed NP events had higher rates of resolution, compared with non-SLE NP events, with the exception of headache, which had similar resolution for both event groups.

“Resolution of SLE events was more likely in patients with Asian race/ethnicity and those with Central/Focal nervous system disease with no effect seen for age at diagnosis,” the researchers noted. “For non-SLE NP events, African race/ethnicity at non-U.S. sites and younger age at diagnosis was associated with a better outcome.”

The study findings were limited by several factors including the predominantly White patient population and the clustering of NP events into limited categories, which may have reduced the identification of more specific associations, the researchers noted. Also, the assessment of NP event outcomes did not include patient perceptions, and the relatively short follow-up period does not allow for assessment of later NP events such as cerebrovascular disease. However, “despite these limitations the current study provides valuable data on the presentation, outcome and predictors of NP disease in SLE patients enrolled in a long-term, international, disease inception cohort,” the researchers concluded.

The study received no outside funding. Dr. Hanly was supported by a grant from the Canadian Institutes of Health Research but had no financial conflicts to disclose. Several coauthors received grant support from various institutions, but not from industry, and had no financial conflicts to disclose.

Different kinds of neuropsychiatric (NP) events in patients with systemic lupus erythematosus (SLE) have substantial variability in their occurrence, resolution, and recurrence over time, as well as in their predictors, according to new research from a large, prospective, international, inception cohort study.

Because “multiple NP events due to different causes may present concurrently in individual patients, the findings emphasize the importance of recognizing attribution of NP events as a determinant of clinical outcome,” John G. Hanly, MD, of Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, N.S., and colleagues wrote in Arthritis & Rheumatology.

In a previous study of the same group of 1,827 patients with SLE, NP events occurred in about half and approximately one-third of these events were deemed disease related. They also “occurred most frequently around the diagnosis of SLE and had a significant negative impact on health-related quality of life,” the researchers wrote.

Researchers involved with the Systemic Lupus International Collaborating Clinics recruited the 1,827 adults with SLE over an 11-year period during 1999-2011 from a total of 31 sites in Europe, Asia, and North America. The average age of the patients at study enrollment was 35 years, 89% were women, and 49% were White. The mean disease duration was 5.6 months, and 70% of patients were taking corticosteroids at enrollment.

Over an average follow-up period of 7.6 years, 955 patients (52.3%) experienced a single neuropsychiatric event, and 493 (27.0%) experienced two or more events; the total number of unique NP events was 1,910. Most of these unique events (92%) involved the central nervous system, and 8.4% involved the peripheral nervous system.

The researchers used multistate models to attribute NP events to SLE based on factors that included the temporal onset of NP events in relation to SLE diagnosis, concurrent non-SLE factors, and NP events that are common in healthy controls. The four states in the multistate models were no NP events, no current NP event but a history of at least one event, new or ongoing NP events, and death. The results included a multivariate analysis of a model involving 492 observed transitions into new or ongoing NP events.

In the multivariate analysis, factors positively associated with SLE-attributed NP events included male sex (hazard ratio, 1.35; P = .028), concurrent non-SLE NP events excluding headache (HR, 1.83; P < .001), active SLE based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (HR, 1.19; P = .012), and corticosteroid use (HR, 1.59; P = .008). The researchers also found that SLE-attributed NP events were negatively associated with Asian race/ethnicity, postsecondary education, and use of immunosuppressive drugs.

Another multivariate analysis found that non-SLE NP events were positively associated with only concurrent SLE-attributed NP events excluding headache (HR, 2.31; P < .001), but negative associations were seen with non-U.S. African race/ethnicity and Asian race/ethnicity.

The researchers found that SLE-attributed NP events had higher rates of resolution, compared with non-SLE NP events, with the exception of headache, which had similar resolution for both event groups.

“Resolution of SLE events was more likely in patients with Asian race/ethnicity and those with Central/Focal nervous system disease with no effect seen for age at diagnosis,” the researchers noted. “For non-SLE NP events, African race/ethnicity at non-U.S. sites and younger age at diagnosis was associated with a better outcome.”

The study findings were limited by several factors including the predominantly White patient population and the clustering of NP events into limited categories, which may have reduced the identification of more specific associations, the researchers noted. Also, the assessment of NP event outcomes did not include patient perceptions, and the relatively short follow-up period does not allow for assessment of later NP events such as cerebrovascular disease. However, “despite these limitations the current study provides valuable data on the presentation, outcome and predictors of NP disease in SLE patients enrolled in a long-term, international, disease inception cohort,” the researchers concluded.

The study received no outside funding. Dr. Hanly was supported by a grant from the Canadian Institutes of Health Research but had no financial conflicts to disclose. Several coauthors received grant support from various institutions, but not from industry, and had no financial conflicts to disclose.

Different kinds of neuropsychiatric (NP) events in patients with systemic lupus erythematosus (SLE) have substantial variability in their occurrence, resolution, and recurrence over time, as well as in their predictors, according to new research from a large, prospective, international, inception cohort study.

Because “multiple NP events due to different causes may present concurrently in individual patients, the findings emphasize the importance of recognizing attribution of NP events as a determinant of clinical outcome,” John G. Hanly, MD, of Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, N.S., and colleagues wrote in Arthritis & Rheumatology.

In a previous study of the same group of 1,827 patients with SLE, NP events occurred in about half and approximately one-third of these events were deemed disease related. They also “occurred most frequently around the diagnosis of SLE and had a significant negative impact on health-related quality of life,” the researchers wrote.

Researchers involved with the Systemic Lupus International Collaborating Clinics recruited the 1,827 adults with SLE over an 11-year period during 1999-2011 from a total of 31 sites in Europe, Asia, and North America. The average age of the patients at study enrollment was 35 years, 89% were women, and 49% were White. The mean disease duration was 5.6 months, and 70% of patients were taking corticosteroids at enrollment.

Over an average follow-up period of 7.6 years, 955 patients (52.3%) experienced a single neuropsychiatric event, and 493 (27.0%) experienced two or more events; the total number of unique NP events was 1,910. Most of these unique events (92%) involved the central nervous system, and 8.4% involved the peripheral nervous system.

The researchers used multistate models to attribute NP events to SLE based on factors that included the temporal onset of NP events in relation to SLE diagnosis, concurrent non-SLE factors, and NP events that are common in healthy controls. The four states in the multistate models were no NP events, no current NP event but a history of at least one event, new or ongoing NP events, and death. The results included a multivariate analysis of a model involving 492 observed transitions into new or ongoing NP events.

In the multivariate analysis, factors positively associated with SLE-attributed NP events included male sex (hazard ratio, 1.35; P = .028), concurrent non-SLE NP events excluding headache (HR, 1.83; P < .001), active SLE based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (HR, 1.19; P = .012), and corticosteroid use (HR, 1.59; P = .008). The researchers also found that SLE-attributed NP events were negatively associated with Asian race/ethnicity, postsecondary education, and use of immunosuppressive drugs.

Another multivariate analysis found that non-SLE NP events were positively associated with only concurrent SLE-attributed NP events excluding headache (HR, 2.31; P < .001), but negative associations were seen with non-U.S. African race/ethnicity and Asian race/ethnicity.

The researchers found that SLE-attributed NP events had higher rates of resolution, compared with non-SLE NP events, with the exception of headache, which had similar resolution for both event groups.

“Resolution of SLE events was more likely in patients with Asian race/ethnicity and those with Central/Focal nervous system disease with no effect seen for age at diagnosis,” the researchers noted. “For non-SLE NP events, African race/ethnicity at non-U.S. sites and younger age at diagnosis was associated with a better outcome.”

The study findings were limited by several factors including the predominantly White patient population and the clustering of NP events into limited categories, which may have reduced the identification of more specific associations, the researchers noted. Also, the assessment of NP event outcomes did not include patient perceptions, and the relatively short follow-up period does not allow for assessment of later NP events such as cerebrovascular disease. However, “despite these limitations the current study provides valuable data on the presentation, outcome and predictors of NP disease in SLE patients enrolled in a long-term, international, disease inception cohort,” the researchers concluded.

The study received no outside funding. Dr. Hanly was supported by a grant from the Canadian Institutes of Health Research but had no financial conflicts to disclose. Several coauthors received grant support from various institutions, but not from industry, and had no financial conflicts to disclose.