For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

Self-measured blood pressure (SMBP) monitoring at home is a validated approach to measure out-of-office BP that has the potential to improve the detection and control of hypertension, according to a joint policy statement from the American Heart Association (AHA) and American Medical Association (AMA).

“With fewer patients visiting medical offices during the COVID-19 pandemic, SMBP monitoring is more important than ever for people at risk for hypertension and uncontrolled BP,” writing group chair Daichi Shimbo, MD, said in a statement.

“There should be investment in creating and supporting the infrastructure for expanding self-measured BP monitoring, as well as increasing coverage for patient- and provider-related costs,” Dr. Shimbo, director, The Columbia Hypertension Center, Columbia University Irving Medical Center, New York, said in an interview.

The statement, Self-Measured Blood Pressure Monitoring at Home, was published June 22 in Circulation.

It provides “contemporary information” on the use, efficacy, and cost-effectiveness of SMBP at home for the diagnosis and management of hypertension.

The writing group noted that hypertension is one of the most important risk factors for cardiovascular disease. Several American and international guidelines support the use of SMBP.

“Indications include the diagnosis of white-coat hypertension and masked hypertension and the identification of white-coat effect and masked uncontrolled hypertension. Other indications include confirming the diagnosis of resistant hypertension and detecting morning hypertension,” the group pointed out.

Use validated devices

Devices that are validated for clinical accuracy should be used for SMBP monitoring, the writing group advised. Validated devices that use the oscillometric method are preferred, and a standardized BP measurement (with appropriately sized cuffs) and monitoring protocol should be followed.

The group noted that meta-analyses of randomized trials indicate that SMBP monitoring is associated with a reduction in BP and improved BP control, and the benefits are greatest when it is used along with other interventions, such as education and counseling, that can be delivered via phone or telehealth visits by nurses and care coordinators.

There are “sufficient data” to indicate that adding SMBP monitoring to office-based monitoring is cost-effective compared with office BP monitoring alone or usual care in patients with high office BP, the writing group said.

Potential cost savings associated with SMBP monitoring include a reduction in office visit follow-ups as a result of improved BP control, avoidance of possible overtreatment in patients with white-coat hypertension, and improvement in quality of life.

They noted that randomized controlled trials assessing the impact of SMBP monitoring on cardiovascular outcomes are needed.

Barriers to widespread use

The use of SMBP monitoring is “essential” for the self-management of hypertension and has “great appeal” for expanding the benefits of cardiovascular prevention, the writing group said. They acknowledged, however, that transitioning from solely office-based BP management to a strategy that includes SMBP monitoring is not without actual and potential barriers.

The group recommends addressing these barriers by:

• Educating patients and providers about the benefits of SMBP monitoring and the optimal approaches for SMBP monitoring.
• Establishing clinical core competency criteria to ensure high-quality SMBP monitoring is supported in clinical practice.
• Incorporating cointerventions that increase the effectiveness of SMBP monitoring, including behavioral change management and counseling, communication of treatment recommendations back to patients, medication management, and prescription and adherence monitoring.
• Creating systems for SMBP readings to be transferred from devices to electronic health records.
• Improving public and private health insurance coverage of validated SMBP monitoring devices prescribed by a health care provider.
• Reimbursing providers for costs associated with training patients, transmitting BP data, interpreting and reporting BP readings, and delivering cointerventions.

Increasing the use of SMBP monitoring is a major focus area of Target: BP – a national initiative of the AHA and AMA launched in response to the high prevalence of uncontrolled BP.

Target: BP helps health care organizations and care teams improve BP control rates through the evidence-based MAP BP Program.

MAP is an acronym that stands for Measure BP accurately every time it’s measured, Act rapidly to manage uncontrolled BP, and Partner with patients to promote BP self-management.

This research had no commercial funding. Dr. Shimbo has disclosed no relevant conflicts of interest. A complete list of disclosures for the writing group is available with the original article.
 

A version of this article originally appeared on Medscape.com.

Self-measured blood pressure (SMBP) monitoring at home is a validated approach to measure out-of-office BP that has the potential to improve the detection and control of hypertension, according to a joint policy statement from the American Heart Association (AHA) and American Medical Association (AMA).

“With fewer patients visiting medical offices during the COVID-19 pandemic, SMBP monitoring is more important than ever for people at risk for hypertension and uncontrolled BP,” writing group chair Daichi Shimbo, MD, said in a statement.

“There should be investment in creating and supporting the infrastructure for expanding self-measured BP monitoring, as well as increasing coverage for patient- and provider-related costs,” Dr. Shimbo, director, The Columbia Hypertension Center, Columbia University Irving Medical Center, New York, said in an interview.

The statement, Self-Measured Blood Pressure Monitoring at Home, was published June 22 in Circulation.

It provides “contemporary information” on the use, efficacy, and cost-effectiveness of SMBP at home for the diagnosis and management of hypertension.

The writing group noted that hypertension is one of the most important risk factors for cardiovascular disease. Several American and international guidelines support the use of SMBP.

“Indications include the diagnosis of white-coat hypertension and masked hypertension and the identification of white-coat effect and masked uncontrolled hypertension. Other indications include confirming the diagnosis of resistant hypertension and detecting morning hypertension,” the group pointed out.

Use validated devices

Devices that are validated for clinical accuracy should be used for SMBP monitoring, the writing group advised. Validated devices that use the oscillometric method are preferred, and a standardized BP measurement (with appropriately sized cuffs) and monitoring protocol should be followed.

The group noted that meta-analyses of randomized trials indicate that SMBP monitoring is associated with a reduction in BP and improved BP control, and the benefits are greatest when it is used along with other interventions, such as education and counseling, that can be delivered via phone or telehealth visits by nurses and care coordinators.

There are “sufficient data” to indicate that adding SMBP monitoring to office-based monitoring is cost-effective compared with office BP monitoring alone or usual care in patients with high office BP, the writing group said.

Potential cost savings associated with SMBP monitoring include a reduction in office visit follow-ups as a result of improved BP control, avoidance of possible overtreatment in patients with white-coat hypertension, and improvement in quality of life.

They noted that randomized controlled trials assessing the impact of SMBP monitoring on cardiovascular outcomes are needed.

Barriers to widespread use

The use of SMBP monitoring is “essential” for the self-management of hypertension and has “great appeal” for expanding the benefits of cardiovascular prevention, the writing group said. They acknowledged, however, that transitioning from solely office-based BP management to a strategy that includes SMBP monitoring is not without actual and potential barriers.

The group recommends addressing these barriers by:

• Educating patients and providers about the benefits of SMBP monitoring and the optimal approaches for SMBP monitoring.
• Establishing clinical core competency criteria to ensure high-quality SMBP monitoring is supported in clinical practice.
• Incorporating cointerventions that increase the effectiveness of SMBP monitoring, including behavioral change management and counseling, communication of treatment recommendations back to patients, medication management, and prescription and adherence monitoring.
• Creating systems for SMBP readings to be transferred from devices to electronic health records.
• Improving public and private health insurance coverage of validated SMBP monitoring devices prescribed by a health care provider.
• Reimbursing providers for costs associated with training patients, transmitting BP data, interpreting and reporting BP readings, and delivering cointerventions.

Increasing the use of SMBP monitoring is a major focus area of Target: BP – a national initiative of the AHA and AMA launched in response to the high prevalence of uncontrolled BP.

Target: BP helps health care organizations and care teams improve BP control rates through the evidence-based MAP BP Program.

MAP is an acronym that stands for Measure BP accurately every time it’s measured, Act rapidly to manage uncontrolled BP, and Partner with patients to promote BP self-management.

This research had no commercial funding. Dr. Shimbo has disclosed no relevant conflicts of interest. A complete list of disclosures for the writing group is available with the original article.
 

A version of this article originally appeared on Medscape.com.

Self-measured blood pressure (SMBP) monitoring at home is a validated approach to measure out-of-office BP that has the potential to improve the detection and control of hypertension, according to a joint policy statement from the American Heart Association (AHA) and American Medical Association (AMA).

“With fewer patients visiting medical offices during the COVID-19 pandemic, SMBP monitoring is more important than ever for people at risk for hypertension and uncontrolled BP,” writing group chair Daichi Shimbo, MD, said in a statement.

“There should be investment in creating and supporting the infrastructure for expanding self-measured BP monitoring, as well as increasing coverage for patient- and provider-related costs,” Dr. Shimbo, director, The Columbia Hypertension Center, Columbia University Irving Medical Center, New York, said in an interview.

The statement, Self-Measured Blood Pressure Monitoring at Home, was published June 22 in Circulation.

It provides “contemporary information” on the use, efficacy, and cost-effectiveness of SMBP at home for the diagnosis and management of hypertension.

The writing group noted that hypertension is one of the most important risk factors for cardiovascular disease. Several American and international guidelines support the use of SMBP.

“Indications include the diagnosis of white-coat hypertension and masked hypertension and the identification of white-coat effect and masked uncontrolled hypertension. Other indications include confirming the diagnosis of resistant hypertension and detecting morning hypertension,” the group pointed out.

Use validated devices

Devices that are validated for clinical accuracy should be used for SMBP monitoring, the writing group advised. Validated devices that use the oscillometric method are preferred, and a standardized BP measurement (with appropriately sized cuffs) and monitoring protocol should be followed.

The group noted that meta-analyses of randomized trials indicate that SMBP monitoring is associated with a reduction in BP and improved BP control, and the benefits are greatest when it is used along with other interventions, such as education and counseling, that can be delivered via phone or telehealth visits by nurses and care coordinators.

There are “sufficient data” to indicate that adding SMBP monitoring to office-based monitoring is cost-effective compared with office BP monitoring alone or usual care in patients with high office BP, the writing group said.

Potential cost savings associated with SMBP monitoring include a reduction in office visit follow-ups as a result of improved BP control, avoidance of possible overtreatment in patients with white-coat hypertension, and improvement in quality of life.

They noted that randomized controlled trials assessing the impact of SMBP monitoring on cardiovascular outcomes are needed.

Barriers to widespread use

The use of SMBP monitoring is “essential” for the self-management of hypertension and has “great appeal” for expanding the benefits of cardiovascular prevention, the writing group said. They acknowledged, however, that transitioning from solely office-based BP management to a strategy that includes SMBP monitoring is not without actual and potential barriers.

The group recommends addressing these barriers by:

• Educating patients and providers about the benefits of SMBP monitoring and the optimal approaches for SMBP monitoring.
• Establishing clinical core competency criteria to ensure high-quality SMBP monitoring is supported in clinical practice.
• Incorporating cointerventions that increase the effectiveness of SMBP monitoring, including behavioral change management and counseling, communication of treatment recommendations back to patients, medication management, and prescription and adherence monitoring.
• Creating systems for SMBP readings to be transferred from devices to electronic health records.
• Improving public and private health insurance coverage of validated SMBP monitoring devices prescribed by a health care provider.
• Reimbursing providers for costs associated with training patients, transmitting BP data, interpreting and reporting BP readings, and delivering cointerventions.

Increasing the use of SMBP monitoring is a major focus area of Target: BP – a national initiative of the AHA and AMA launched in response to the high prevalence of uncontrolled BP.

Target: BP helps health care organizations and care teams improve BP control rates through the evidence-based MAP BP Program.

MAP is an acronym that stands for Measure BP accurately every time it’s measured, Act rapidly to manage uncontrolled BP, and Partner with patients to promote BP self-management.

This research had no commercial funding. Dr. Shimbo has disclosed no relevant conflicts of interest. A complete list of disclosures for the writing group is available with the original article.
 

A version of this article originally appeared on Medscape.com.

Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.

Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.

“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.

The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.

This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.

“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.

Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.

The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.

The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.

“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”

Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”

Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.

In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.

Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.

“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.

Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.

“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.

Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.

Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.

“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.

The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.

This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.

“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.

Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.

The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.

The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.

“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”

Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”

Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.

In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.

Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.

“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.

Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.

“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.

Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.

Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.

“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.

The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.

This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.

“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.

Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.

The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.

The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.

“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”

Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”

Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.

In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.

Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.

“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.

Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.

“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

The objectives also balance specificity to the topic with a timeless quality, allowing for flexibility both as new information emerges and when applied to various educational activities and learner groups. Each chapter can stand alone, and thus themes recur if one reads the compendium in its entirety. However, in order to reflect related content among the chapters, the appendix contains a list of associated chapters (Chapter Links) for further exploration. In addition, a short reference list is provided in each chapter to reflect the literature and best practices at the time of publication.

Finally, The PHM Core Competencies: 2020 Revision reflect the status of children as a vulnerable population. Care for hospitalized children requires attention to many elements unique to the pediatric population. These include age-based differences in development, behavior, physiology, and prevalence of clinical conditions, the impact of acute and chronic disease states on child development, the use of medications and other medical interventions with limited investigative guidance, and the role of caregivers in decision-making and care delivery. Heightened awareness of these factors is required in the hospital setting, where diagnoses and interventions often include the use of high-risk modalities and require coordination of care across multiple providers.

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

The objectives also balance specificity to the topic with a timeless quality, allowing for flexibility both as new information emerges and when applied to various educational activities and learner groups. Each chapter can stand alone, and thus themes recur if one reads the compendium in its entirety. However, in order to reflect related content among the chapters, the appendix contains a list of associated chapters (Chapter Links) for further exploration. In addition, a short reference list is provided in each chapter to reflect the literature and best practices at the time of publication.

Finally, The PHM Core Competencies: 2020 Revision reflect the status of children as a vulnerable population. Care for hospitalized children requires attention to many elements unique to the pediatric population. These include age-based differences in development, behavior, physiology, and prevalence of clinical conditions, the impact of acute and chronic disease states on child development, the use of medications and other medical interventions with limited investigative guidance, and the role of caregivers in decision-making and care delivery. Heightened awareness of these factors is required in the hospital setting, where diagnoses and interventions often include the use of high-risk modalities and require coordination of care across multiple providers.

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

The objectives also balance specificity to the topic with a timeless quality, allowing for flexibility both as new information emerges and when applied to various educational activities and learner groups. Each chapter can stand alone, and thus themes recur if one reads the compendium in its entirety. However, in order to reflect related content among the chapters, the appendix contains a list of associated chapters (Chapter Links) for further exploration. In addition, a short reference list is provided in each chapter to reflect the literature and best practices at the time of publication.

Finally, The PHM Core Competencies: 2020 Revision reflect the status of children as a vulnerable population. Care for hospitalized children requires attention to many elements unique to the pediatric population. These include age-based differences in development, behavior, physiology, and prevalence of clinical conditions, the impact of acute and chronic disease states on child development, the use of medications and other medical interventions with limited investigative guidance, and the role of caregivers in decision-making and care delivery. Heightened awareness of these factors is required in the hospital setting, where diagnoses and interventions often include the use of high-risk modalities and require coordination of care across multiple providers.

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

Tirofiban is far superior to cangrelor at achieving rapid and potent inhibition of platelet aggregation in patients undergoing primary percutaneous coronary intervention for ST-elevation MI.

Frontline Medical News

And cangrelor, in turn, is superior to oral prasugrel, according to the randomized FABOLUS FASTER trial, Marco Valgimigli, MD, PhD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, contrary to conventional wisdom, chewed prasugrel (Effient) proved no better than swallowing the tablets whole for platelet inhibition, said Dr. Valgimigli, an interventional cardiologist at the University of Bern (Switzerland).

He explained that standard administration of the newer oral P2Y12 inhibitors prasugrel and ticagrelor (Brilinta) in patients undergoing percutaneous coronary intervention (PCI) for ST-elevation MI (STEMI) does not provide optimal early inhibition of platelet aggregation. The parenteral antiplatelet drugs tirofiban and cangrelor have been shown to provide faster and more prolonged inhibition of platelet aggregation than the oral P2Y12 inhibitors.

But there has been no head-to-head comparative data for the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat) and the P2Y12 inhibitor cangrelor (Kengreal) in the setting of primary PCI for STEMI. This was the impetus for FABOLUS FASTER, the first study to compare the pharmacodynamic effects of the two parenteral antiplatelet agents. The trial also looked at how these potent parenteral drugs, compared with chewed prasugrel, another previously unexamined yet highly practical issue.

The three-center, multinational, open-label FABOLUS FASTER trial randomized 122 patients undergoing primary PCI for STEMI to one of three arms: a standard intravenous bolus and 2-hour infusion of either the P2Y12 inhibitor cangrelor (Kengreal) or the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat), followed in either case by 60 mg of oral prasugrel, or a third arm in which patients didn’t receive either drug but were instead randomized to a 60-mg loading dose of chewed or whole prasugrel tablets.

The primary study endpoint was inhibition of platelet aggregation at 30 minutes as measured by light transmittance aggregometry in response to 20 mcmol/L of adenosine diphosphate (ADP).

Tirofiban was the unequivocal winner with 95% inhibition, as compared with 34.1% with cangrelor, 10.5% with chewed prasugrel, and 6.3% with prasugrel swallowed whole, even though the concentration of prasugrel’s active metabolite was far greater at 62.3 ng/mL after prasugrel was chewed, compared with 17.1 ng/mL when swallowed in integral tablet form.

The rate of nonresponsiveness to tirofiban as defined by greater than 59% platelet aggregation was zero for tirofiban during its 2-hour infusion, then a scant 8% thereafter during repeated testing at 3 and 4-6 hours. In contrast, the cangrelor nonresponsiveness rate was 50%-58% during the 2-hour infusion, rising to 82% at 3 hours.

FABOLUS FASTER, while not powered for clinical endpoints, might nevertheless have important clinical implications, according to Dr. Valgimigli. First, the superiority of the intravenous drugs tirofiban and cangrelor over prasugrel for early, strong platelet inhibition underscores the importance of giving parenteral antiplatelet drugs over oral therapy during the acute phase of STEMI therapy. Moreover, tirofiban’s outstanding performance – and the high residual platelet reactivity associated with cangrelor – makes a strong case for large comparative, randomized trials of the two drugs, with hard clinical endpoints.

Bruce Jancin/Frontline Medical News

Discussant Christoph K. Naber, MD, PhD, opined that he personally doesn’t consider the FABOLUS FASTER results practice changing, for a couple of reasons.

“Platelet inhibition measured by ADP in vitro is not necessarily related to true effects in vivo. We know that platelets are activated by multiple mechanisms, and the ADP pathway is just one of them,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

Also, there’s a good reason why no glycoprotein IIb/IIIA inhibitors are approved for treatment of STEMI, and why tirofiban, despite its impressive antiplatelet effects, is currently largely reserved for bailout situations, such as complex lesions with large thrombus burden. It’s because tirofiban’s potent antiplatelet activity is accompanied by a high risk of bleeding, he added.

However, Dr. Valgimigli noted that this conviction about excessive bleeding risk is mainly based on older studies in which glycoprotein IIb/IIIA inhibitors were administered for prolonged duration through femoral access sites. He argued that it’s time for large clinical trials examining the risk/benefit ratio of short infusion of these agents in the contemporary practice of primary PCI for STEMI.

Simultaneously with Dr. Valgimigli’s presentation, the FABOLUS FASTER results were published online (Circulation. 2020 Jun 27; doi: 10.1161/CIRCULATIONAHA.120.046928).

Dr. Valgimigli reported that Medicure, the sponsor of the FABOLUS FASTER trial, provided an institutional research grant to conduct the study. He also disclosed receiving research grants and personal fees outside the scope of this study from a dozen pharmaceutical and medical device companies. Dr. Naber reported having no financial conflicts.

bjancin@mdedge.com

Tirofiban is far superior to cangrelor at achieving rapid and potent inhibition of platelet aggregation in patients undergoing primary percutaneous coronary intervention for ST-elevation MI.

Frontline Medical News

And cangrelor, in turn, is superior to oral prasugrel, according to the randomized FABOLUS FASTER trial, Marco Valgimigli, MD, PhD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, contrary to conventional wisdom, chewed prasugrel (Effient) proved no better than swallowing the tablets whole for platelet inhibition, said Dr. Valgimigli, an interventional cardiologist at the University of Bern (Switzerland).

He explained that standard administration of the newer oral P2Y12 inhibitors prasugrel and ticagrelor (Brilinta) in patients undergoing percutaneous coronary intervention (PCI) for ST-elevation MI (STEMI) does not provide optimal early inhibition of platelet aggregation. The parenteral antiplatelet drugs tirofiban and cangrelor have been shown to provide faster and more prolonged inhibition of platelet aggregation than the oral P2Y12 inhibitors.

But there has been no head-to-head comparative data for the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat) and the P2Y12 inhibitor cangrelor (Kengreal) in the setting of primary PCI for STEMI. This was the impetus for FABOLUS FASTER, the first study to compare the pharmacodynamic effects of the two parenteral antiplatelet agents. The trial also looked at how these potent parenteral drugs, compared with chewed prasugrel, another previously unexamined yet highly practical issue.

The three-center, multinational, open-label FABOLUS FASTER trial randomized 122 patients undergoing primary PCI for STEMI to one of three arms: a standard intravenous bolus and 2-hour infusion of either the P2Y12 inhibitor cangrelor (Kengreal) or the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat), followed in either case by 60 mg of oral prasugrel, or a third arm in which patients didn’t receive either drug but were instead randomized to a 60-mg loading dose of chewed or whole prasugrel tablets.

The primary study endpoint was inhibition of platelet aggregation at 30 minutes as measured by light transmittance aggregometry in response to 20 mcmol/L of adenosine diphosphate (ADP).

Tirofiban was the unequivocal winner with 95% inhibition, as compared with 34.1% with cangrelor, 10.5% with chewed prasugrel, and 6.3% with prasugrel swallowed whole, even though the concentration of prasugrel’s active metabolite was far greater at 62.3 ng/mL after prasugrel was chewed, compared with 17.1 ng/mL when swallowed in integral tablet form.

The rate of nonresponsiveness to tirofiban as defined by greater than 59% platelet aggregation was zero for tirofiban during its 2-hour infusion, then a scant 8% thereafter during repeated testing at 3 and 4-6 hours. In contrast, the cangrelor nonresponsiveness rate was 50%-58% during the 2-hour infusion, rising to 82% at 3 hours.

FABOLUS FASTER, while not powered for clinical endpoints, might nevertheless have important clinical implications, according to Dr. Valgimigli. First, the superiority of the intravenous drugs tirofiban and cangrelor over prasugrel for early, strong platelet inhibition underscores the importance of giving parenteral antiplatelet drugs over oral therapy during the acute phase of STEMI therapy. Moreover, tirofiban’s outstanding performance – and the high residual platelet reactivity associated with cangrelor – makes a strong case for large comparative, randomized trials of the two drugs, with hard clinical endpoints.

Bruce Jancin/Frontline Medical News

Discussant Christoph K. Naber, MD, PhD, opined that he personally doesn’t consider the FABOLUS FASTER results practice changing, for a couple of reasons.

“Platelet inhibition measured by ADP in vitro is not necessarily related to true effects in vivo. We know that platelets are activated by multiple mechanisms, and the ADP pathway is just one of them,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

Also, there’s a good reason why no glycoprotein IIb/IIIA inhibitors are approved for treatment of STEMI, and why tirofiban, despite its impressive antiplatelet effects, is currently largely reserved for bailout situations, such as complex lesions with large thrombus burden. It’s because tirofiban’s potent antiplatelet activity is accompanied by a high risk of bleeding, he added.

However, Dr. Valgimigli noted that this conviction about excessive bleeding risk is mainly based on older studies in which glycoprotein IIb/IIIA inhibitors were administered for prolonged duration through femoral access sites. He argued that it’s time for large clinical trials examining the risk/benefit ratio of short infusion of these agents in the contemporary practice of primary PCI for STEMI.

Simultaneously with Dr. Valgimigli’s presentation, the FABOLUS FASTER results were published online (Circulation. 2020 Jun 27; doi: 10.1161/CIRCULATIONAHA.120.046928).

Dr. Valgimigli reported that Medicure, the sponsor of the FABOLUS FASTER trial, provided an institutional research grant to conduct the study. He also disclosed receiving research grants and personal fees outside the scope of this study from a dozen pharmaceutical and medical device companies. Dr. Naber reported having no financial conflicts.

bjancin@mdedge.com

Tirofiban is far superior to cangrelor at achieving rapid and potent inhibition of platelet aggregation in patients undergoing primary percutaneous coronary intervention for ST-elevation MI.

Frontline Medical News

And cangrelor, in turn, is superior to oral prasugrel, according to the randomized FABOLUS FASTER trial, Marco Valgimigli, MD, PhD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, contrary to conventional wisdom, chewed prasugrel (Effient) proved no better than swallowing the tablets whole for platelet inhibition, said Dr. Valgimigli, an interventional cardiologist at the University of Bern (Switzerland).

He explained that standard administration of the newer oral P2Y12 inhibitors prasugrel and ticagrelor (Brilinta) in patients undergoing percutaneous coronary intervention (PCI) for ST-elevation MI (STEMI) does not provide optimal early inhibition of platelet aggregation. The parenteral antiplatelet drugs tirofiban and cangrelor have been shown to provide faster and more prolonged inhibition of platelet aggregation than the oral P2Y12 inhibitors.

But there has been no head-to-head comparative data for the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat) and the P2Y12 inhibitor cangrelor (Kengreal) in the setting of primary PCI for STEMI. This was the impetus for FABOLUS FASTER, the first study to compare the pharmacodynamic effects of the two parenteral antiplatelet agents. The trial also looked at how these potent parenteral drugs, compared with chewed prasugrel, another previously unexamined yet highly practical issue.

The three-center, multinational, open-label FABOLUS FASTER trial randomized 122 patients undergoing primary PCI for STEMI to one of three arms: a standard intravenous bolus and 2-hour infusion of either the P2Y12 inhibitor cangrelor (Kengreal) or the glycoprotein IIb/IIIA inhibitor tirofiban (Aggrastat), followed in either case by 60 mg of oral prasugrel, or a third arm in which patients didn’t receive either drug but were instead randomized to a 60-mg loading dose of chewed or whole prasugrel tablets.

The primary study endpoint was inhibition of platelet aggregation at 30 minutes as measured by light transmittance aggregometry in response to 20 mcmol/L of adenosine diphosphate (ADP).

Tirofiban was the unequivocal winner with 95% inhibition, as compared with 34.1% with cangrelor, 10.5% with chewed prasugrel, and 6.3% with prasugrel swallowed whole, even though the concentration of prasugrel’s active metabolite was far greater at 62.3 ng/mL after prasugrel was chewed, compared with 17.1 ng/mL when swallowed in integral tablet form.

The rate of nonresponsiveness to tirofiban as defined by greater than 59% platelet aggregation was zero for tirofiban during its 2-hour infusion, then a scant 8% thereafter during repeated testing at 3 and 4-6 hours. In contrast, the cangrelor nonresponsiveness rate was 50%-58% during the 2-hour infusion, rising to 82% at 3 hours.

FABOLUS FASTER, while not powered for clinical endpoints, might nevertheless have important clinical implications, according to Dr. Valgimigli. First, the superiority of the intravenous drugs tirofiban and cangrelor over prasugrel for early, strong platelet inhibition underscores the importance of giving parenteral antiplatelet drugs over oral therapy during the acute phase of STEMI therapy. Moreover, tirofiban’s outstanding performance – and the high residual platelet reactivity associated with cangrelor – makes a strong case for large comparative, randomized trials of the two drugs, with hard clinical endpoints.

Bruce Jancin/Frontline Medical News

Discussant Christoph K. Naber, MD, PhD, opined that he personally doesn’t consider the FABOLUS FASTER results practice changing, for a couple of reasons.

“Platelet inhibition measured by ADP in vitro is not necessarily related to true effects in vivo. We know that platelets are activated by multiple mechanisms, and the ADP pathway is just one of them,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

Also, there’s a good reason why no glycoprotein IIb/IIIA inhibitors are approved for treatment of STEMI, and why tirofiban, despite its impressive antiplatelet effects, is currently largely reserved for bailout situations, such as complex lesions with large thrombus burden. It’s because tirofiban’s potent antiplatelet activity is accompanied by a high risk of bleeding, he added.

However, Dr. Valgimigli noted that this conviction about excessive bleeding risk is mainly based on older studies in which glycoprotein IIb/IIIA inhibitors were administered for prolonged duration through femoral access sites. He argued that it’s time for large clinical trials examining the risk/benefit ratio of short infusion of these agents in the contemporary practice of primary PCI for STEMI.

Simultaneously with Dr. Valgimigli’s presentation, the FABOLUS FASTER results were published online (Circulation. 2020 Jun 27; doi: 10.1161/CIRCULATIONAHA.120.046928).

Dr. Valgimigli reported that Medicure, the sponsor of the FABOLUS FASTER trial, provided an institutional research grant to conduct the study. He also disclosed receiving research grants and personal fees outside the scope of this study from a dozen pharmaceutical and medical device companies. Dr. Naber reported having no financial conflicts.

bjancin@mdedge.com

Sotatercept, a first-in-class fusion protein designed to reduce vascular remodeling, significantly decreased pulmonary vascular resistance for patients with pulmonary arterial hypertension (PAH) in a phase 2 trial.

The mean decline change in pulmonary vascular resistance (PVR) after 24 weeks of treatment was significantly greater for patients treated with sotatercept at either of two doses, compared with placebo, David B. Badesch, MD, FCCP, of the University of Colorado, Aurora, reported on behalf of coinvestigators in the PULSAR trial.

“Sotatercept has a novel mechanism of action, rebalancing pro- and antiproliferative signaling through a pathway distinct from the previously approved pulmonary arterial hypertension therapies,” he said in the American Thoracic Society’s virtual clinical trial session.

The drug is a ligand trap with high selectivity for proteins within the tumor growth factor-beta superfamily signaling pathway. Investigators propose a mechanism of action whereby sotatercept promotes a rebalancing of bone morphogenetic protein receptor–II (BMPR-II) signaling to restore vascular homeostasis.

In a preclinical study, sotatercept reduced pulmonary artery pressure, pulmonary arteriolar muscularization and occlusion, right ventricular hypertrophy, and cell proliferation in the lungs of rodent models of pulmonary hypertension (Sci Transl Med. 2020 May 13. doi: 10.1126/scitranslmed.aaz5660).
 

Two dose levels

The PULSAR trial (NCT03496207) was a phase 2 randomized, double-blind study conducted in the United States, Brazil, Western Europe, and Australia comparing the efficacy and safety of sotatercept vs. placebo added to the standard of care in patients with PAH.

A total of 106 patients with World Health Organization (WHO) group 1 PAH or WHO functional class II or III disease were enrolled. All patients had baseline right-heart e4rcatheterization with PVR of 5 Wood units or more, had baseline 6-minute walk distance from 150 to 550 m, and were on stable treatment with standard-of-care mono, double, or triple therapies, including an endothelin-receptor antagonist, phosphodiesterase 5 inhibitor, soluble guanylate cyclase stimulator, and/or a prostacyclin, including intravenous formulations.

The median patient age was 46 years among 32 patients in the placebo group, and 48.5 years in each sotatercept dose group: 0.3 mg/kg (32 patients) and 0.7 mg/kg (42 patients).

The primary endpoint of PVR change from baseline to week 24, the end of the placebo-controlled treatment period, showed a mean decrease of 162 dynes/cm² in the 0.3-mg/kg sotatercept group (–20.5%), and a mean decrease of 256 dynes/cm² in the 0.7-mg/kg group (–33.9%), compared with a mean 16 dyne/cm² decline in the placebo group (–2,1%). Both doses were associated with significantly larger decreases, compared with placebo (P = .0027 for the 0.3-mg/kg dose, and P < .0001 for the 0.7-mg/kg dose).

Six-minute walk distance, a key secondary endpoint, improved over baseline in each active-drug arm, with a least square (LS) mean improvement of 58 m in the 0.7-mg/kg group, and 50 m in the 0.7-mg/kg group. The prespecified analysis of pooled data from the two sotatercept cohorts showed an LS-mean change of 54 m over baseline, compared with 25 m for the placebo group (nominal P = .03).

Exploratory endpoints also favoring sotatercept over placebo included a 51% reduction in amino-terminal brain natriuretic propeptide (NT-proBNP), and a 20% reduction in mean pulmonary arterial pressure.

There was no significant difference between the study arms in change in cardiac output, however.

Improvements in WHO functional class were seen in 12.5% of patients on placebo, compared with 23% of patients on sotatercept, a difference that was not statistically significant.

Two patients (6%) in the 0.3-mg/kg arm and 10 (24%) in the 0.7-mg/kg arm had a serious treatment-emergent adverse event (TEAE), as did three patients (9%) in the placebo arm. Serious TEAEs included leukopenia, neutropenia, pericardial infusion, tachycardia, chorioretinopathy, peripheral edema, pyrexia, bronchitis, influenza, respiratory tract infection, femur fracture, hypotension, device breakage, syncope, and red blood cell increase.

One patient in the 0.7-mg/kg arm died from cardiac arrest deemed unrelated to study treatment.

TEAEs of special interest included thrombocytopenia in two patients in 0.3– and five patients in the 0.7–mg/kg groups, vs. no patients in the placebo groups. Most patients had existing thrombocytopenia at baseline and all were on concomitant prostacyclin infusions. No patients had grade 3 thrombocytopenia or associated bleeding events.

One patient in the 0.3-mg/kg group and six patients in the 0.7-mg/kg group had an increase in hemoglobin.

“This was not a surprise,” Dr. Badesch said. “We were prepared to manage increases in hemoglobin with dose interruption or dose reduction if necessary, and phlebotomy was also an option if needed.”

One patient in the placebo arm, two in the 0.3-mg/kg and three patients in the 0.7-mg/kg arms had TEAEs leading to discontinuation.

TEAEs occurring in 10% or more of all patients in any arm and of any grade were headache, diarrhea, peripheral edema, dizziness, fatigue, hypokalemia, and nausea.
 

Why no cardiac improvement?

In the question-and-answer session following the online presentation, facilitator Steven M. Kawut MD, MS, of the University of Pennsylvania and Pennsylvania Hospital in Philadelphia, remarked on the surprising lack of an apparent cardiac benefit in the study.

“You showed pretty robust decreases in NT-proBNP, decreases in pulmonary vascular resistance and right atrial pressure, and increases in 6-minute walk distance, so it’s a bit surprising that cardiac output didn’t change,” he said.

“Unlike other medications that have been tried in this field and have had a significant pulmonary vasodilatory effect, this drug is acting largely on the structure of pulmonary blood vessels,” Dr. Badesch replied. “We have thought that its primary effect is likely remodeling of the pulmonary arteries and arterioles, decreasing pulmonary vascular resistance. Unlike other drugs that have been tested in the field, it probably has no direct inotropic effect, and that may explain why cardiac output didn’t improve.”

He said that there is some echocardiographic evidence that suggests a change in right ventricular function over time. Those data are currently being analyzed, and “it’s possible that we’ll see an effect on cardiac output later.”

As of June 22, 2020, 94 of 97 patients who opted to participate in an 18-month extension period of the trial were still enrolled, and 64 patients have now been treated with sotatercept for at least 12 months.

A phase 3 trial is in the works.

The study was supported by Acceleron Pharma. Badesch disclosed research support from and consulting/advising for the company and others. Dr. Kawut has disclosed grants from several companies and travel support from ATS and the Pulmonary Hypertension Association.

Sotatercept, a first-in-class fusion protein designed to reduce vascular remodeling, significantly decreased pulmonary vascular resistance for patients with pulmonary arterial hypertension (PAH) in a phase 2 trial.

The mean decline change in pulmonary vascular resistance (PVR) after 24 weeks of treatment was significantly greater for patients treated with sotatercept at either of two doses, compared with placebo, David B. Badesch, MD, FCCP, of the University of Colorado, Aurora, reported on behalf of coinvestigators in the PULSAR trial.

“Sotatercept has a novel mechanism of action, rebalancing pro- and antiproliferative signaling through a pathway distinct from the previously approved pulmonary arterial hypertension therapies,” he said in the American Thoracic Society’s virtual clinical trial session.

The drug is a ligand trap with high selectivity for proteins within the tumor growth factor-beta superfamily signaling pathway. Investigators propose a mechanism of action whereby sotatercept promotes a rebalancing of bone morphogenetic protein receptor–II (BMPR-II) signaling to restore vascular homeostasis.

In a preclinical study, sotatercept reduced pulmonary artery pressure, pulmonary arteriolar muscularization and occlusion, right ventricular hypertrophy, and cell proliferation in the lungs of rodent models of pulmonary hypertension (Sci Transl Med. 2020 May 13. doi: 10.1126/scitranslmed.aaz5660).
 

Two dose levels

The PULSAR trial (NCT03496207) was a phase 2 randomized, double-blind study conducted in the United States, Brazil, Western Europe, and Australia comparing the efficacy and safety of sotatercept vs. placebo added to the standard of care in patients with PAH.

A total of 106 patients with World Health Organization (WHO) group 1 PAH or WHO functional class II or III disease were enrolled. All patients had baseline right-heart e4rcatheterization with PVR of 5 Wood units or more, had baseline 6-minute walk distance from 150 to 550 m, and were on stable treatment with standard-of-care mono, double, or triple therapies, including an endothelin-receptor antagonist, phosphodiesterase 5 inhibitor, soluble guanylate cyclase stimulator, and/or a prostacyclin, including intravenous formulations.

The median patient age was 46 years among 32 patients in the placebo group, and 48.5 years in each sotatercept dose group: 0.3 mg/kg (32 patients) and 0.7 mg/kg (42 patients).

The primary endpoint of PVR change from baseline to week 24, the end of the placebo-controlled treatment period, showed a mean decrease of 162 dynes/cm² in the 0.3-mg/kg sotatercept group (–20.5%), and a mean decrease of 256 dynes/cm² in the 0.7-mg/kg group (–33.9%), compared with a mean 16 dyne/cm² decline in the placebo group (–2,1%). Both doses were associated with significantly larger decreases, compared with placebo (P = .0027 for the 0.3-mg/kg dose, and P < .0001 for the 0.7-mg/kg dose).

Six-minute walk distance, a key secondary endpoint, improved over baseline in each active-drug arm, with a least square (LS) mean improvement of 58 m in the 0.7-mg/kg group, and 50 m in the 0.7-mg/kg group. The prespecified analysis of pooled data from the two sotatercept cohorts showed an LS-mean change of 54 m over baseline, compared with 25 m for the placebo group (nominal P = .03).

Exploratory endpoints also favoring sotatercept over placebo included a 51% reduction in amino-terminal brain natriuretic propeptide (NT-proBNP), and a 20% reduction in mean pulmonary arterial pressure.

There was no significant difference between the study arms in change in cardiac output, however.

Improvements in WHO functional class were seen in 12.5% of patients on placebo, compared with 23% of patients on sotatercept, a difference that was not statistically significant.

Two patients (6%) in the 0.3-mg/kg arm and 10 (24%) in the 0.7-mg/kg arm had a serious treatment-emergent adverse event (TEAE), as did three patients (9%) in the placebo arm. Serious TEAEs included leukopenia, neutropenia, pericardial infusion, tachycardia, chorioretinopathy, peripheral edema, pyrexia, bronchitis, influenza, respiratory tract infection, femur fracture, hypotension, device breakage, syncope, and red blood cell increase.

One patient in the 0.7-mg/kg arm died from cardiac arrest deemed unrelated to study treatment.

TEAEs of special interest included thrombocytopenia in two patients in 0.3– and five patients in the 0.7–mg/kg groups, vs. no patients in the placebo groups. Most patients had existing thrombocytopenia at baseline and all were on concomitant prostacyclin infusions. No patients had grade 3 thrombocytopenia or associated bleeding events.

One patient in the 0.3-mg/kg group and six patients in the 0.7-mg/kg group had an increase in hemoglobin.

“This was not a surprise,” Dr. Badesch said. “We were prepared to manage increases in hemoglobin with dose interruption or dose reduction if necessary, and phlebotomy was also an option if needed.”

One patient in the placebo arm, two in the 0.3-mg/kg and three patients in the 0.7-mg/kg arms had TEAEs leading to discontinuation.

TEAEs occurring in 10% or more of all patients in any arm and of any grade were headache, diarrhea, peripheral edema, dizziness, fatigue, hypokalemia, and nausea.
 

Why no cardiac improvement?

In the question-and-answer session following the online presentation, facilitator Steven M. Kawut MD, MS, of the University of Pennsylvania and Pennsylvania Hospital in Philadelphia, remarked on the surprising lack of an apparent cardiac benefit in the study.

“You showed pretty robust decreases in NT-proBNP, decreases in pulmonary vascular resistance and right atrial pressure, and increases in 6-minute walk distance, so it’s a bit surprising that cardiac output didn’t change,” he said.

“Unlike other medications that have been tried in this field and have had a significant pulmonary vasodilatory effect, this drug is acting largely on the structure of pulmonary blood vessels,” Dr. Badesch replied. “We have thought that its primary effect is likely remodeling of the pulmonary arteries and arterioles, decreasing pulmonary vascular resistance. Unlike other drugs that have been tested in the field, it probably has no direct inotropic effect, and that may explain why cardiac output didn’t improve.”

He said that there is some echocardiographic evidence that suggests a change in right ventricular function over time. Those data are currently being analyzed, and “it’s possible that we’ll see an effect on cardiac output later.”

As of June 22, 2020, 94 of 97 patients who opted to participate in an 18-month extension period of the trial were still enrolled, and 64 patients have now been treated with sotatercept for at least 12 months.

A phase 3 trial is in the works.

The study was supported by Acceleron Pharma. Badesch disclosed research support from and consulting/advising for the company and others. Dr. Kawut has disclosed grants from several companies and travel support from ATS and the Pulmonary Hypertension Association.

Sotatercept, a first-in-class fusion protein designed to reduce vascular remodeling, significantly decreased pulmonary vascular resistance for patients with pulmonary arterial hypertension (PAH) in a phase 2 trial.

The mean decline change in pulmonary vascular resistance (PVR) after 24 weeks of treatment was significantly greater for patients treated with sotatercept at either of two doses, compared with placebo, David B. Badesch, MD, FCCP, of the University of Colorado, Aurora, reported on behalf of coinvestigators in the PULSAR trial.

“Sotatercept has a novel mechanism of action, rebalancing pro- and antiproliferative signaling through a pathway distinct from the previously approved pulmonary arterial hypertension therapies,” he said in the American Thoracic Society’s virtual clinical trial session.

The drug is a ligand trap with high selectivity for proteins within the tumor growth factor-beta superfamily signaling pathway. Investigators propose a mechanism of action whereby sotatercept promotes a rebalancing of bone morphogenetic protein receptor–II (BMPR-II) signaling to restore vascular homeostasis.

In a preclinical study, sotatercept reduced pulmonary artery pressure, pulmonary arteriolar muscularization and occlusion, right ventricular hypertrophy, and cell proliferation in the lungs of rodent models of pulmonary hypertension (Sci Transl Med. 2020 May 13. doi: 10.1126/scitranslmed.aaz5660).
 

Two dose levels

The PULSAR trial (NCT03496207) was a phase 2 randomized, double-blind study conducted in the United States, Brazil, Western Europe, and Australia comparing the efficacy and safety of sotatercept vs. placebo added to the standard of care in patients with PAH.

A total of 106 patients with World Health Organization (WHO) group 1 PAH or WHO functional class II or III disease were enrolled. All patients had baseline right-heart e4rcatheterization with PVR of 5 Wood units or more, had baseline 6-minute walk distance from 150 to 550 m, and were on stable treatment with standard-of-care mono, double, or triple therapies, including an endothelin-receptor antagonist, phosphodiesterase 5 inhibitor, soluble guanylate cyclase stimulator, and/or a prostacyclin, including intravenous formulations.

The median patient age was 46 years among 32 patients in the placebo group, and 48.5 years in each sotatercept dose group: 0.3 mg/kg (32 patients) and 0.7 mg/kg (42 patients).

The primary endpoint of PVR change from baseline to week 24, the end of the placebo-controlled treatment period, showed a mean decrease of 162 dynes/cm² in the 0.3-mg/kg sotatercept group (–20.5%), and a mean decrease of 256 dynes/cm² in the 0.7-mg/kg group (–33.9%), compared with a mean 16 dyne/cm² decline in the placebo group (–2,1%). Both doses were associated with significantly larger decreases, compared with placebo (P = .0027 for the 0.3-mg/kg dose, and P < .0001 for the 0.7-mg/kg dose).

Six-minute walk distance, a key secondary endpoint, improved over baseline in each active-drug arm, with a least square (LS) mean improvement of 58 m in the 0.7-mg/kg group, and 50 m in the 0.7-mg/kg group. The prespecified analysis of pooled data from the two sotatercept cohorts showed an LS-mean change of 54 m over baseline, compared with 25 m for the placebo group (nominal P = .03).

Exploratory endpoints also favoring sotatercept over placebo included a 51% reduction in amino-terminal brain natriuretic propeptide (NT-proBNP), and a 20% reduction in mean pulmonary arterial pressure.

There was no significant difference between the study arms in change in cardiac output, however.

Improvements in WHO functional class were seen in 12.5% of patients on placebo, compared with 23% of patients on sotatercept, a difference that was not statistically significant.

Two patients (6%) in the 0.3-mg/kg arm and 10 (24%) in the 0.7-mg/kg arm had a serious treatment-emergent adverse event (TEAE), as did three patients (9%) in the placebo arm. Serious TEAEs included leukopenia, neutropenia, pericardial infusion, tachycardia, chorioretinopathy, peripheral edema, pyrexia, bronchitis, influenza, respiratory tract infection, femur fracture, hypotension, device breakage, syncope, and red blood cell increase.

One patient in the 0.7-mg/kg arm died from cardiac arrest deemed unrelated to study treatment.

TEAEs of special interest included thrombocytopenia in two patients in 0.3– and five patients in the 0.7–mg/kg groups, vs. no patients in the placebo groups. Most patients had existing thrombocytopenia at baseline and all were on concomitant prostacyclin infusions. No patients had grade 3 thrombocytopenia or associated bleeding events.

One patient in the 0.3-mg/kg group and six patients in the 0.7-mg/kg group had an increase in hemoglobin.

“This was not a surprise,” Dr. Badesch said. “We were prepared to manage increases in hemoglobin with dose interruption or dose reduction if necessary, and phlebotomy was also an option if needed.”

One patient in the placebo arm, two in the 0.3-mg/kg and three patients in the 0.7-mg/kg arms had TEAEs leading to discontinuation.

TEAEs occurring in 10% or more of all patients in any arm and of any grade were headache, diarrhea, peripheral edema, dizziness, fatigue, hypokalemia, and nausea.
 

Why no cardiac improvement?

In the question-and-answer session following the online presentation, facilitator Steven M. Kawut MD, MS, of the University of Pennsylvania and Pennsylvania Hospital in Philadelphia, remarked on the surprising lack of an apparent cardiac benefit in the study.

“You showed pretty robust decreases in NT-proBNP, decreases in pulmonary vascular resistance and right atrial pressure, and increases in 6-minute walk distance, so it’s a bit surprising that cardiac output didn’t change,” he said.

“Unlike other medications that have been tried in this field and have had a significant pulmonary vasodilatory effect, this drug is acting largely on the structure of pulmonary blood vessels,” Dr. Badesch replied. “We have thought that its primary effect is likely remodeling of the pulmonary arteries and arterioles, decreasing pulmonary vascular resistance. Unlike other drugs that have been tested in the field, it probably has no direct inotropic effect, and that may explain why cardiac output didn’t improve.”

He said that there is some echocardiographic evidence that suggests a change in right ventricular function over time. Those data are currently being analyzed, and “it’s possible that we’ll see an effect on cardiac output later.”

As of June 22, 2020, 94 of 97 patients who opted to participate in an 18-month extension period of the trial were still enrolled, and 64 patients have now been treated with sotatercept for at least 12 months.

A phase 3 trial is in the works.

The study was supported by Acceleron Pharma. Badesch disclosed research support from and consulting/advising for the company and others. Dr. Kawut has disclosed grants from several companies and travel support from ATS and the Pulmonary Hypertension Association.

Sarah Jones, PA-C, is a physician assistant on the overnight hospitalist team at Indiana University Health Methodist Hospital in Indianapolis, where she has worked for about 8 years. She studied chemistry and biology as an undergraduate at the University of Indianapolis, and then attended PA school at Butler University in Indianapolis. She came out as lesbian/queer just before PA school. She joined the Society of Hospital Medicine in 2020 and serves on SHM’s Diversity and Inclusion Special Interest Group.

How important is it to you to openly identify as a physician assistant who is a member of the LGBTQ community?

I think it’s important to show other people that I am part of the LGBTQ community and that I’ve been able to overcome obstacles and pursue this career and be successful. I can help other people and be in that role [of mentor], and show people that they can do it, too.

What challenges have you faced because of your sexual orientation in the different stages of your career, from training to practicing as a physician assistant?

When my training started, I was much closer to the time when I came out, so my confidence level was a little bit low. I was much more fearful at that point about how people would view me – if I would be thought of as inferior, or not taken as seriously, or that I wasn’t intelligent. I think over the years I’ve grown into this role and it’s helped me become more confident, because I know who I am now. And it’s not something that definitely defines me but I’m confident that I know medicine, and I know how to treat patients and that confidence has gotten much better.

So far at work, everyone’s been great, all my coworkers have been great. I’ve never once felt that my sexuality was holding anyone back from getting to know me better.
 

Have you heard about the experiences of other LGBTQ clinicians who may not have been as fortunate as you, especially transgender people?

There is just a lot of ignorance around LGBTQ persons and especially transgender persons, because people don’t understand it, they don’t get it. So their first inclination is to not approve of it, or be scared of it, or just automatically think that it’s wrong.

If someone’s sexuality comes across much more “obviously” than that of other people, for example, if there’s a gay man who’s a little more flamboyant, [it could be an issue for some patients]. I know there are some gay male nurses who have had patients who don’t want them serving as their nurse, because they’re “obviously” gay. Or a queer woman clinician who has more of an edgier haircut or looks a little bit more masculine; I know that there have been some patients who have said certain things to them that have been discriminating.
 

Have you been especially conscious of how you ‘wear’ your sexual orientation? Have you ever had to change how you’ve presented yourself, lest you have some unpleasant reaction?

I think initially, yes. I would say I’m a little more on the androgynous side with my style. When I was coming out I was trying to figure out where I was and who I was and how I wanted to be, and for the longest time I was dressing more femininely and I wasn’t as comfortable. Since then, I’ve had times where I’ve had short hair or a little bit more of a masculine haircut and wear more masculine clothes and things like that, and I feel much more comfortable doing that.

It’s kind of hard to play the part of a more masculine LGBTQ person at work when you just wear scrubs. I probably don’t portray it as much – I don’t make it as obvious as some other people, but I’ve definitely never shied away from having a conversation with anyone about it.
 

Health care is an intimate profession because of your close interaction with patients and others. Did being a member of the LGBTQ community factor into your decision to enter the health care field, either for or against?

There were times when I didn’t feel well or my mental health was not great because I didn’t know where I was, or hadn’t accepted myself, and I really needed someone who could help me talk through things and try to figure out what my life path was going to be. When I figured those things out with the help of other people, it was life-changing. I respected those people, and that’s what I wanted to do and how I wanted to help. I think that was part of why I got into medicine.

What progress have you seen with regard to LGBTQ health care professionals and patients over the past 5 to 10 years, including subtle changes in culture, attitude, or workplace policies?

Just being interviewed for a profile like this is a step in the right direction. Never once did I think that I would be highlighted for being an LGBTQ person, especially in the workplace.

I think that there are more companies, particularly in health care, and more hospitals that are coming out in support of their LGBTQ employees, especially during Pride month. IU Health walks every year in the Pride parade, which last year was about 3 hours long. Five years previously it was only 30 minutes long. So there are more employers getting involved and recognizing their employees as well. Companies and health care facilities are trying to be more cognizant of their LGBTQ employees and patients and trying to make them more comfortable.
 

What main steps toward more progress would you like to see?

There needs to be greater understanding that people who undergo discrimination actually have more negative health outcomes like heart disease, high blood pressure, and stroke. There needs to be better medical coverage in the LGBTQ community, especially for transgender persons and LGBTQ people who are trying to start families. We need better mental health access, more affordable mental health access, particularly for LGBTQ youth, and we definitely need to continue to raise awareness with hopes that we can eradicate the violence against, and killing of, black transgender persons.

How do you see the Society of Hospital Medicine’s role in this regard?

SHM has a big platform and can certainly reach a lot of people, especially hospitalists who see LGBTQ patients every day. With SHM’s help and the continued training of hospitalists who are members of the society, we can reach out to other clinicians, and to their organizations, and help teach them. SHM really has a good platform to be able to do that, and do it well.

Can you recall a specific interaction with an LGBTQ patient that left you with a potent feeling that “this is what it’s all about”?

I do remember a transgender patient who was homeless. They didn’t have insurance, they couldn’t afford their hormone treatment, and I remember they were struggling with some mental health issues and were “acting out” overnight. Some of the nurses were not using the correct pronouns. I’m more cognizant of their struggles because I’m a member of the LGBTQ community and I was able to recognize this.

I sat down and I talked with the patient for quite a while, we were able to form a bond, and I was able to get a little bit more information from them, and by the end of the night, they felt much better. And just being able to be their voice, when they weren’t able to express exactly how they were feeling, was something that made me thankful that I went into medicine, to help other LGBTQ patients.

I’ve had many LGBTQ patients in the hospital whom I’ve been able to form a bit of a bond with, just knowing that the patient could be me.

Sarah Jones, PA-C, is a physician assistant on the overnight hospitalist team at Indiana University Health Methodist Hospital in Indianapolis, where she has worked for about 8 years. She studied chemistry and biology as an undergraduate at the University of Indianapolis, and then attended PA school at Butler University in Indianapolis. She came out as lesbian/queer just before PA school. She joined the Society of Hospital Medicine in 2020 and serves on SHM’s Diversity and Inclusion Special Interest Group.

How important is it to you to openly identify as a physician assistant who is a member of the LGBTQ community?

I think it’s important to show other people that I am part of the LGBTQ community and that I’ve been able to overcome obstacles and pursue this career and be successful. I can help other people and be in that role [of mentor], and show people that they can do it, too.

What challenges have you faced because of your sexual orientation in the different stages of your career, from training to practicing as a physician assistant?

When my training started, I was much closer to the time when I came out, so my confidence level was a little bit low. I was much more fearful at that point about how people would view me – if I would be thought of as inferior, or not taken as seriously, or that I wasn’t intelligent. I think over the years I’ve grown into this role and it’s helped me become more confident, because I know who I am now. And it’s not something that definitely defines me but I’m confident that I know medicine, and I know how to treat patients and that confidence has gotten much better.

So far at work, everyone’s been great, all my coworkers have been great. I’ve never once felt that my sexuality was holding anyone back from getting to know me better.
 

Have you heard about the experiences of other LGBTQ clinicians who may not have been as fortunate as you, especially transgender people?

There is just a lot of ignorance around LGBTQ persons and especially transgender persons, because people don’t understand it, they don’t get it. So their first inclination is to not approve of it, or be scared of it, or just automatically think that it’s wrong.

If someone’s sexuality comes across much more “obviously” than that of other people, for example, if there’s a gay man who’s a little more flamboyant, [it could be an issue for some patients]. I know there are some gay male nurses who have had patients who don’t want them serving as their nurse, because they’re “obviously” gay. Or a queer woman clinician who has more of an edgier haircut or looks a little bit more masculine; I know that there have been some patients who have said certain things to them that have been discriminating.
 

Have you been especially conscious of how you ‘wear’ your sexual orientation? Have you ever had to change how you’ve presented yourself, lest you have some unpleasant reaction?

I think initially, yes. I would say I’m a little more on the androgynous side with my style. When I was coming out I was trying to figure out where I was and who I was and how I wanted to be, and for the longest time I was dressing more femininely and I wasn’t as comfortable. Since then, I’ve had times where I’ve had short hair or a little bit more of a masculine haircut and wear more masculine clothes and things like that, and I feel much more comfortable doing that.

It’s kind of hard to play the part of a more masculine LGBTQ person at work when you just wear scrubs. I probably don’t portray it as much – I don’t make it as obvious as some other people, but I’ve definitely never shied away from having a conversation with anyone about it.
 

Health care is an intimate profession because of your close interaction with patients and others. Did being a member of the LGBTQ community factor into your decision to enter the health care field, either for or against?

There were times when I didn’t feel well or my mental health was not great because I didn’t know where I was, or hadn’t accepted myself, and I really needed someone who could help me talk through things and try to figure out what my life path was going to be. When I figured those things out with the help of other people, it was life-changing. I respected those people, and that’s what I wanted to do and how I wanted to help. I think that was part of why I got into medicine.

What progress have you seen with regard to LGBTQ health care professionals and patients over the past 5 to 10 years, including subtle changes in culture, attitude, or workplace policies?

Just being interviewed for a profile like this is a step in the right direction. Never once did I think that I would be highlighted for being an LGBTQ person, especially in the workplace.

I think that there are more companies, particularly in health care, and more hospitals that are coming out in support of their LGBTQ employees, especially during Pride month. IU Health walks every year in the Pride parade, which last year was about 3 hours long. Five years previously it was only 30 minutes long. So there are more employers getting involved and recognizing their employees as well. Companies and health care facilities are trying to be more cognizant of their LGBTQ employees and patients and trying to make them more comfortable.
 

What main steps toward more progress would you like to see?

There needs to be greater understanding that people who undergo discrimination actually have more negative health outcomes like heart disease, high blood pressure, and stroke. There needs to be better medical coverage in the LGBTQ community, especially for transgender persons and LGBTQ people who are trying to start families. We need better mental health access, more affordable mental health access, particularly for LGBTQ youth, and we definitely need to continue to raise awareness with hopes that we can eradicate the violence against, and killing of, black transgender persons.

How do you see the Society of Hospital Medicine’s role in this regard?

SHM has a big platform and can certainly reach a lot of people, especially hospitalists who see LGBTQ patients every day. With SHM’s help and the continued training of hospitalists who are members of the society, we can reach out to other clinicians, and to their organizations, and help teach them. SHM really has a good platform to be able to do that, and do it well.

Can you recall a specific interaction with an LGBTQ patient that left you with a potent feeling that “this is what it’s all about”?

I do remember a transgender patient who was homeless. They didn’t have insurance, they couldn’t afford their hormone treatment, and I remember they were struggling with some mental health issues and were “acting out” overnight. Some of the nurses were not using the correct pronouns. I’m more cognizant of their struggles because I’m a member of the LGBTQ community and I was able to recognize this.

I sat down and I talked with the patient for quite a while, we were able to form a bond, and I was able to get a little bit more information from them, and by the end of the night, they felt much better. And just being able to be their voice, when they weren’t able to express exactly how they were feeling, was something that made me thankful that I went into medicine, to help other LGBTQ patients.

I’ve had many LGBTQ patients in the hospital whom I’ve been able to form a bit of a bond with, just knowing that the patient could be me.

Sarah Jones, PA-C, is a physician assistant on the overnight hospitalist team at Indiana University Health Methodist Hospital in Indianapolis, where she has worked for about 8 years. She studied chemistry and biology as an undergraduate at the University of Indianapolis, and then attended PA school at Butler University in Indianapolis. She came out as lesbian/queer just before PA school. She joined the Society of Hospital Medicine in 2020 and serves on SHM’s Diversity and Inclusion Special Interest Group.

How important is it to you to openly identify as a physician assistant who is a member of the LGBTQ community?

I think it’s important to show other people that I am part of the LGBTQ community and that I’ve been able to overcome obstacles and pursue this career and be successful. I can help other people and be in that role [of mentor], and show people that they can do it, too.

What challenges have you faced because of your sexual orientation in the different stages of your career, from training to practicing as a physician assistant?

When my training started, I was much closer to the time when I came out, so my confidence level was a little bit low. I was much more fearful at that point about how people would view me – if I would be thought of as inferior, or not taken as seriously, or that I wasn’t intelligent. I think over the years I’ve grown into this role and it’s helped me become more confident, because I know who I am now. And it’s not something that definitely defines me but I’m confident that I know medicine, and I know how to treat patients and that confidence has gotten much better.

So far at work, everyone’s been great, all my coworkers have been great. I’ve never once felt that my sexuality was holding anyone back from getting to know me better.
 

Have you heard about the experiences of other LGBTQ clinicians who may not have been as fortunate as you, especially transgender people?

There is just a lot of ignorance around LGBTQ persons and especially transgender persons, because people don’t understand it, they don’t get it. So their first inclination is to not approve of it, or be scared of it, or just automatically think that it’s wrong.

If someone’s sexuality comes across much more “obviously” than that of other people, for example, if there’s a gay man who’s a little more flamboyant, [it could be an issue for some patients]. I know there are some gay male nurses who have had patients who don’t want them serving as their nurse, because they’re “obviously” gay. Or a queer woman clinician who has more of an edgier haircut or looks a little bit more masculine; I know that there have been some patients who have said certain things to them that have been discriminating.
 

Have you been especially conscious of how you ‘wear’ your sexual orientation? Have you ever had to change how you’ve presented yourself, lest you have some unpleasant reaction?

I think initially, yes. I would say I’m a little more on the androgynous side with my style. When I was coming out I was trying to figure out where I was and who I was and how I wanted to be, and for the longest time I was dressing more femininely and I wasn’t as comfortable. Since then, I’ve had times where I’ve had short hair or a little bit more of a masculine haircut and wear more masculine clothes and things like that, and I feel much more comfortable doing that.

It’s kind of hard to play the part of a more masculine LGBTQ person at work when you just wear scrubs. I probably don’t portray it as much – I don’t make it as obvious as some other people, but I’ve definitely never shied away from having a conversation with anyone about it.
 

Health care is an intimate profession because of your close interaction with patients and others. Did being a member of the LGBTQ community factor into your decision to enter the health care field, either for or against?

There were times when I didn’t feel well or my mental health was not great because I didn’t know where I was, or hadn’t accepted myself, and I really needed someone who could help me talk through things and try to figure out what my life path was going to be. When I figured those things out with the help of other people, it was life-changing. I respected those people, and that’s what I wanted to do and how I wanted to help. I think that was part of why I got into medicine.

What progress have you seen with regard to LGBTQ health care professionals and patients over the past 5 to 10 years, including subtle changes in culture, attitude, or workplace policies?

Just being interviewed for a profile like this is a step in the right direction. Never once did I think that I would be highlighted for being an LGBTQ person, especially in the workplace.

I think that there are more companies, particularly in health care, and more hospitals that are coming out in support of their LGBTQ employees, especially during Pride month. IU Health walks every year in the Pride parade, which last year was about 3 hours long. Five years previously it was only 30 minutes long. So there are more employers getting involved and recognizing their employees as well. Companies and health care facilities are trying to be more cognizant of their LGBTQ employees and patients and trying to make them more comfortable.
 

What main steps toward more progress would you like to see?

There needs to be greater understanding that people who undergo discrimination actually have more negative health outcomes like heart disease, high blood pressure, and stroke. There needs to be better medical coverage in the LGBTQ community, especially for transgender persons and LGBTQ people who are trying to start families. We need better mental health access, more affordable mental health access, particularly for LGBTQ youth, and we definitely need to continue to raise awareness with hopes that we can eradicate the violence against, and killing of, black transgender persons.

How do you see the Society of Hospital Medicine’s role in this regard?

SHM has a big platform and can certainly reach a lot of people, especially hospitalists who see LGBTQ patients every day. With SHM’s help and the continued training of hospitalists who are members of the society, we can reach out to other clinicians, and to their organizations, and help teach them. SHM really has a good platform to be able to do that, and do it well.

Can you recall a specific interaction with an LGBTQ patient that left you with a potent feeling that “this is what it’s all about”?

I do remember a transgender patient who was homeless. They didn’t have insurance, they couldn’t afford their hormone treatment, and I remember they were struggling with some mental health issues and were “acting out” overnight. Some of the nurses were not using the correct pronouns. I’m more cognizant of their struggles because I’m a member of the LGBTQ community and I was able to recognize this.

I sat down and I talked with the patient for quite a while, we were able to form a bond, and I was able to get a little bit more information from them, and by the end of the night, they felt much better. And just being able to be their voice, when they weren’t able to express exactly how they were feeling, was something that made me thankful that I went into medicine, to help other LGBTQ patients.

I’ve had many LGBTQ patients in the hospital whom I’ve been able to form a bit of a bond with, just knowing that the patient could be me.

Two new studies offer positive news about medical cannabis, suggesting that marijuana products improve physical and cognitive symptoms, boost quality of life, and rarely produce signs of problematic use.

Anatoliy Sizov/Getty Images

In one study, patients with epilepsy who used medical cannabis were nearly half as likely to have needed an emergency department visit within the last 30 days as was a control group. In the other study, 3 of 54 subjects who used medical cannabis showed signs of possible cannabis use disorder (CUD) over 12 months.

The findings show that “there is improvement in a range of outcome variables, and the adverse effects seem to be minimal, compared to what we might have hypothesized based on the bulk of the literature on the negative effects of cannabis on health outcomes,” cannabis researcher Ziva Cooper, PhD, of the University of California at Los Angeles, said in an interview. Dr. Cooper moderated a session about the studies at the virtual annual meeting of the College on Problems of Drug Dependence.

In one study, cannabis researcher Ryan Vandrey, PhD, of Johns Hopkins University, Baltimore, and colleagues compared medical cannabis users (number, 808; mean age, 38; percentage female, 63%) to a control group of people who were interested in medical cannabis (n, 468; mean age, 35; percentage female, 62%).

In both groups, 79% were White. The groups had similar levels of primary medical conditions, such as neurologic (38% and 36%, respectively, for the medical cannabis group and control group) and chronic pain (25% and 23%, respectively.)

The wide majority of those in the medical cannabis group – 58% – were cannabidiol (CBD) users, relying on a component of cannabis (marijuana) that does not make people high. Fewer than 20% used tetrahydrocannabinol (THC), which does make people high, or a combination of both CBD and THC.

Most of those in the medical cannabis group used the drug as an adjunct (39%) to other treatments or last-resort (29%) treatment instead of first line (11%) or second line (18%).

In patients with epilepsy, about 45% of controls reported a past-month ED visit, compared with about 25% of medical cannabis users. The gap in past-month hospital admissions was even wider, at about 35% for the controls and about 15% for the medical cannabis.

After an initial survey, the researchers followed subjects prospectively; some either started or stopped using medical cannabis. From baseline to follow-up, those in the medical cannabis group improved more, compared with those in the control group on a variety of measures of quality of life, anxiety, and depression.

“Folks who were in the control condition at baseline and then initiated cannabis use started to look more like the baseline cannabis users,” Dr. Vandrey said. “The folks who were cannabis users at baseline and then stopped for whatever reason started to look like the controls. And the controls [who never started using medical cannabis] stayed the same.”

As for adverse effects, two-thirds of medical cannabis users reported no problems; the highest number, 14%, reported high cost.

As for limitations, Dr. Vandrey reported missing data, a reliance on self-reports, and poor follow-up with about a third of participants agreeing to complete follow-up assessments. “We are continuing to collect data on this,” he said, “and we’re hoping we’ll be able to drill down more as we get bigger.”

The study was funded by the Realm of Caring Foundation.

In the other study, led by cannabis researcher Staci Gruber, PhD, of McLean Hospital in Belmont, Mass., and Harvard Medical School in Boston, researchers tracked 54 subjects (mean age, 49; 20 male and 34 female; 48 white) for up to 2 years after they began medical cannabis use. Most had pain (36) or anxiety/PTSD (31), and all had to have abstained from recreational cannabis use for at least 1 year.

At follow-ups, the users reported improved mood and anxiety via various measures, and they saw some improvement in quality of life. “We did not see worsening cognitive performance,” Dr. Gruber said. “In fact, we saw improved performance or no change on measures of executive function, in contrast to what we see in the literature.”

Research has suggested that as many as 30% of recreational cannabis users develop cannabis use disorder (CUD), Dr. Gruber said. But only 3 of the 54 patients showed signs of possible CUD at 12 months, she said, even though frequency of use jumped substantially vs. baseline.

Information about study funding was not available.

Dr. Cooper disclosed relationships with FSD Pharma, Beckley Canopy Therapeutics, and Insys Therapeutics. Dr. Vandrey disclosed work with Zynerba Pharmaceuticals, Canopy Health Innovations, and FSD Pharma. Dr. Gruber reported no disclosures.

Two new studies offer positive news about medical cannabis, suggesting that marijuana products improve physical and cognitive symptoms, boost quality of life, and rarely produce signs of problematic use.

Anatoliy Sizov/Getty Images

In one study, patients with epilepsy who used medical cannabis were nearly half as likely to have needed an emergency department visit within the last 30 days as was a control group. In the other study, 3 of 54 subjects who used medical cannabis showed signs of possible cannabis use disorder (CUD) over 12 months.

The findings show that “there is improvement in a range of outcome variables, and the adverse effects seem to be minimal, compared to what we might have hypothesized based on the bulk of the literature on the negative effects of cannabis on health outcomes,” cannabis researcher Ziva Cooper, PhD, of the University of California at Los Angeles, said in an interview. Dr. Cooper moderated a session about the studies at the virtual annual meeting of the College on Problems of Drug Dependence.

In one study, cannabis researcher Ryan Vandrey, PhD, of Johns Hopkins University, Baltimore, and colleagues compared medical cannabis users (number, 808; mean age, 38; percentage female, 63%) to a control group of people who were interested in medical cannabis (n, 468; mean age, 35; percentage female, 62%).

In both groups, 79% were White. The groups had similar levels of primary medical conditions, such as neurologic (38% and 36%, respectively, for the medical cannabis group and control group) and chronic pain (25% and 23%, respectively.)

The wide majority of those in the medical cannabis group – 58% – were cannabidiol (CBD) users, relying on a component of cannabis (marijuana) that does not make people high. Fewer than 20% used tetrahydrocannabinol (THC), which does make people high, or a combination of both CBD and THC.

Most of those in the medical cannabis group used the drug as an adjunct (39%) to other treatments or last-resort (29%) treatment instead of first line (11%) or second line (18%).

In patients with epilepsy, about 45% of controls reported a past-month ED visit, compared with about 25% of medical cannabis users. The gap in past-month hospital admissions was even wider, at about 35% for the controls and about 15% for the medical cannabis.

After an initial survey, the researchers followed subjects prospectively; some either started or stopped using medical cannabis. From baseline to follow-up, those in the medical cannabis group improved more, compared with those in the control group on a variety of measures of quality of life, anxiety, and depression.

“Folks who were in the control condition at baseline and then initiated cannabis use started to look more like the baseline cannabis users,” Dr. Vandrey said. “The folks who were cannabis users at baseline and then stopped for whatever reason started to look like the controls. And the controls [who never started using medical cannabis] stayed the same.”

As for adverse effects, two-thirds of medical cannabis users reported no problems; the highest number, 14%, reported high cost.

As for limitations, Dr. Vandrey reported missing data, a reliance on self-reports, and poor follow-up with about a third of participants agreeing to complete follow-up assessments. “We are continuing to collect data on this,” he said, “and we’re hoping we’ll be able to drill down more as we get bigger.”

The study was funded by the Realm of Caring Foundation.

In the other study, led by cannabis researcher Staci Gruber, PhD, of McLean Hospital in Belmont, Mass., and Harvard Medical School in Boston, researchers tracked 54 subjects (mean age, 49; 20 male and 34 female; 48 white) for up to 2 years after they began medical cannabis use. Most had pain (36) or anxiety/PTSD (31), and all had to have abstained from recreational cannabis use for at least 1 year.

At follow-ups, the users reported improved mood and anxiety via various measures, and they saw some improvement in quality of life. “We did not see worsening cognitive performance,” Dr. Gruber said. “In fact, we saw improved performance or no change on measures of executive function, in contrast to what we see in the literature.”

Research has suggested that as many as 30% of recreational cannabis users develop cannabis use disorder (CUD), Dr. Gruber said. But only 3 of the 54 patients showed signs of possible CUD at 12 months, she said, even though frequency of use jumped substantially vs. baseline.

Information about study funding was not available.

Dr. Cooper disclosed relationships with FSD Pharma, Beckley Canopy Therapeutics, and Insys Therapeutics. Dr. Vandrey disclosed work with Zynerba Pharmaceuticals, Canopy Health Innovations, and FSD Pharma. Dr. Gruber reported no disclosures.

Two new studies offer positive news about medical cannabis, suggesting that marijuana products improve physical and cognitive symptoms, boost quality of life, and rarely produce signs of problematic use.

Anatoliy Sizov/Getty Images

In one study, patients with epilepsy who used medical cannabis were nearly half as likely to have needed an emergency department visit within the last 30 days as was a control group. In the other study, 3 of 54 subjects who used medical cannabis showed signs of possible cannabis use disorder (CUD) over 12 months.

The findings show that “there is improvement in a range of outcome variables, and the adverse effects seem to be minimal, compared to what we might have hypothesized based on the bulk of the literature on the negative effects of cannabis on health outcomes,” cannabis researcher Ziva Cooper, PhD, of the University of California at Los Angeles, said in an interview. Dr. Cooper moderated a session about the studies at the virtual annual meeting of the College on Problems of Drug Dependence.

In one study, cannabis researcher Ryan Vandrey, PhD, of Johns Hopkins University, Baltimore, and colleagues compared medical cannabis users (number, 808; mean age, 38; percentage female, 63%) to a control group of people who were interested in medical cannabis (n, 468; mean age, 35; percentage female, 62%).

In both groups, 79% were White. The groups had similar levels of primary medical conditions, such as neurologic (38% and 36%, respectively, for the medical cannabis group and control group) and chronic pain (25% and 23%, respectively.)

The wide majority of those in the medical cannabis group – 58% – were cannabidiol (CBD) users, relying on a component of cannabis (marijuana) that does not make people high. Fewer than 20% used tetrahydrocannabinol (THC), which does make people high, or a combination of both CBD and THC.

Most of those in the medical cannabis group used the drug as an adjunct (39%) to other treatments or last-resort (29%) treatment instead of first line (11%) or second line (18%).

In patients with epilepsy, about 45% of controls reported a past-month ED visit, compared with about 25% of medical cannabis users. The gap in past-month hospital admissions was even wider, at about 35% for the controls and about 15% for the medical cannabis.

After an initial survey, the researchers followed subjects prospectively; some either started or stopped using medical cannabis. From baseline to follow-up, those in the medical cannabis group improved more, compared with those in the control group on a variety of measures of quality of life, anxiety, and depression.

“Folks who were in the control condition at baseline and then initiated cannabis use started to look more like the baseline cannabis users,” Dr. Vandrey said. “The folks who were cannabis users at baseline and then stopped for whatever reason started to look like the controls. And the controls [who never started using medical cannabis] stayed the same.”

As for adverse effects, two-thirds of medical cannabis users reported no problems; the highest number, 14%, reported high cost.

As for limitations, Dr. Vandrey reported missing data, a reliance on self-reports, and poor follow-up with about a third of participants agreeing to complete follow-up assessments. “We are continuing to collect data on this,” he said, “and we’re hoping we’ll be able to drill down more as we get bigger.”

The study was funded by the Realm of Caring Foundation.

In the other study, led by cannabis researcher Staci Gruber, PhD, of McLean Hospital in Belmont, Mass., and Harvard Medical School in Boston, researchers tracked 54 subjects (mean age, 49; 20 male and 34 female; 48 white) for up to 2 years after they began medical cannabis use. Most had pain (36) or anxiety/PTSD (31), and all had to have abstained from recreational cannabis use for at least 1 year.

At follow-ups, the users reported improved mood and anxiety via various measures, and they saw some improvement in quality of life. “We did not see worsening cognitive performance,” Dr. Gruber said. “In fact, we saw improved performance or no change on measures of executive function, in contrast to what we see in the literature.”

Research has suggested that as many as 30% of recreational cannabis users develop cannabis use disorder (CUD), Dr. Gruber said. But only 3 of the 54 patients showed signs of possible CUD at 12 months, she said, even though frequency of use jumped substantially vs. baseline.

Information about study funding was not available.

Dr. Cooper disclosed relationships with FSD Pharma, Beckley Canopy Therapeutics, and Insys Therapeutics. Dr. Vandrey disclosed work with Zynerba Pharmaceuticals, Canopy Health Innovations, and FSD Pharma. Dr. Gruber reported no disclosures.

Naloxone can reverse opioid overdoses, but time is crucial and its effectiveness wanes if medics can’t arrive right away. Now, a new app links overdose victims or their companions to trained volunteers nearby who may be able to administer the drug much faster.

Over a 1-year period, about half of 112 participants in a Philadelphia trial said they’d responded to overdoses via the app, and about half used it to report overdoses, according to a study released at the virtual annual meeting of the College on Problems of Drug Dependence.

“Thanks to the app, there may have been a life saved about twice a month that otherwise wouldn’t have been,” said public health researcher and study coauthor Stephen Lankenau, PhD, of Drexel University, Philadelphia, in an interview.

Philadelphia has the largest opioid overdose rate of any large city, Dr. Lankenau said, and people who overdose are often reluctant to call 911. “Police are often alerted when it’s determined that it’s a drug-related call. They’re concerned that police could show up and someone will get arrested.”

However, the app, called UnityPhilly, doesn’t remove professional medics from the picture. It’s designed to be a supplement to the existing first-response system – “it’s not meant to replace 911” – and allow a faster response to overdoses when minutes matter, Dr. Lankenau said.

“If someone is adamantly opposed to calling 911,” he said, “this may not be the best intervention for them.”

Here’s how the app works: Participants who overdose themselves or witness an overdose can send out an alert to nearby app users. When an alert goes out, the app also attempts to dial 911, although the participant can bypass this.

Nearby responders can reply by pressing “En route” and then go to the address of the overdose with a provided supply of naloxone (Narcan). The amateur responders, many of whom are or were opioid users themselves, are trained in how to administer the drug.

The study authors recruited 112 participants from the Philadelphia neighborhood of Kensington and tracked them from 2019 to 2020. About half (n = 57) reported using opioids within the past 30 days, and those participants had an average age of 42 years, were 54% men, and were 74% non-Hispanic white. Only 19% were employed, and 42% had been recently homeless. Nearly 80% had overdosed before, and all had witnessed overdoses.

The other participants (n = 55), defined as “community members,” had less experience with opioids (44% had misused them before), although 91% had witnessed overdoses. Their average age was 42 years, 56% were women, 53% were employed, and 16% had been recently homeless.

Over a 1-year period, 51% of the opioid-using participants used the app to report an overdose, as did 46% of the community members. The percentages who reported being en route to an overdose was 47% (opioid users) and 46% (community members).

“The idea of people being trained as community responders has been around for quite a while, and there are hundreds of programs across the country. People are willing to carry naloxone and respond if they see an overdose in front of them,” Dr. Lankenau said. “Here, you have people becoming civilian responders to events they wouldn’t otherwise know about. This creates a community of individuals who can help out immediately and augment the work that emergency responders do.”

Opioid users who download the app may be drawn to the idea of responders who are nonjudgmental and supportive, compared with professional medics. “The system has not done well by people with substance abuse disorders,” said addiction medicine specialist Sukhpreet Klaire, MD, of the British Columbia Center on Substance Use in Vancouver. “In terms of overdose reversal, you may prefer that someone else [other than a medic] give you Narcan and support you through this experience. When it’s over after you’re reversed, you have a sudden onset of withdrawal symptoms. You feel terrible, and you don’t want to be sitting in an ambulance. You want to be in a supportive environment.”

As for adverse effects, there was concern that opioid users might take more risks with an app safety net in place. However, no one reported more risky behavior in interviews, Dr. Lankenau said.

The 3-year program costs $215,000, he said, and the next step is to get funding for a Philadelphia citywide trial.

The study was funded by the National Institute of Drug Abuse. Dr. Lankenau reported no relevant disclosures. Dr. Klaire disclosed participating in a research fellowship and a research in addiction medical scholars program, both funded by NIDA.

Naloxone can reverse opioid overdoses, but time is crucial and its effectiveness wanes if medics can’t arrive right away. Now, a new app links overdose victims or their companions to trained volunteers nearby who may be able to administer the drug much faster.

Over a 1-year period, about half of 112 participants in a Philadelphia trial said they’d responded to overdoses via the app, and about half used it to report overdoses, according to a study released at the virtual annual meeting of the College on Problems of Drug Dependence.

“Thanks to the app, there may have been a life saved about twice a month that otherwise wouldn’t have been,” said public health researcher and study coauthor Stephen Lankenau, PhD, of Drexel University, Philadelphia, in an interview.

Philadelphia has the largest opioid overdose rate of any large city, Dr. Lankenau said, and people who overdose are often reluctant to call 911. “Police are often alerted when it’s determined that it’s a drug-related call. They’re concerned that police could show up and someone will get arrested.”

However, the app, called UnityPhilly, doesn’t remove professional medics from the picture. It’s designed to be a supplement to the existing first-response system – “it’s not meant to replace 911” – and allow a faster response to overdoses when minutes matter, Dr. Lankenau said.

“If someone is adamantly opposed to calling 911,” he said, “this may not be the best intervention for them.”

Here’s how the app works: Participants who overdose themselves or witness an overdose can send out an alert to nearby app users. When an alert goes out, the app also attempts to dial 911, although the participant can bypass this.

Nearby responders can reply by pressing “En route” and then go to the address of the overdose with a provided supply of naloxone (Narcan). The amateur responders, many of whom are or were opioid users themselves, are trained in how to administer the drug.

The study authors recruited 112 participants from the Philadelphia neighborhood of Kensington and tracked them from 2019 to 2020. About half (n = 57) reported using opioids within the past 30 days, and those participants had an average age of 42 years, were 54% men, and were 74% non-Hispanic white. Only 19% were employed, and 42% had been recently homeless. Nearly 80% had overdosed before, and all had witnessed overdoses.

The other participants (n = 55), defined as “community members,” had less experience with opioids (44% had misused them before), although 91% had witnessed overdoses. Their average age was 42 years, 56% were women, 53% were employed, and 16% had been recently homeless.

Over a 1-year period, 51% of the opioid-using participants used the app to report an overdose, as did 46% of the community members. The percentages who reported being en route to an overdose was 47% (opioid users) and 46% (community members).

“The idea of people being trained as community responders has been around for quite a while, and there are hundreds of programs across the country. People are willing to carry naloxone and respond if they see an overdose in front of them,” Dr. Lankenau said. “Here, you have people becoming civilian responders to events they wouldn’t otherwise know about. This creates a community of individuals who can help out immediately and augment the work that emergency responders do.”

Opioid users who download the app may be drawn to the idea of responders who are nonjudgmental and supportive, compared with professional medics. “The system has not done well by people with substance abuse disorders,” said addiction medicine specialist Sukhpreet Klaire, MD, of the British Columbia Center on Substance Use in Vancouver. “In terms of overdose reversal, you may prefer that someone else [other than a medic] give you Narcan and support you through this experience. When it’s over after you’re reversed, you have a sudden onset of withdrawal symptoms. You feel terrible, and you don’t want to be sitting in an ambulance. You want to be in a supportive environment.”

As for adverse effects, there was concern that opioid users might take more risks with an app safety net in place. However, no one reported more risky behavior in interviews, Dr. Lankenau said.

The 3-year program costs $215,000, he said, and the next step is to get funding for a Philadelphia citywide trial.

The study was funded by the National Institute of Drug Abuse. Dr. Lankenau reported no relevant disclosures. Dr. Klaire disclosed participating in a research fellowship and a research in addiction medical scholars program, both funded by NIDA.

Naloxone can reverse opioid overdoses, but time is crucial and its effectiveness wanes if medics can’t arrive right away. Now, a new app links overdose victims or their companions to trained volunteers nearby who may be able to administer the drug much faster.

Over a 1-year period, about half of 112 participants in a Philadelphia trial said they’d responded to overdoses via the app, and about half used it to report overdoses, according to a study released at the virtual annual meeting of the College on Problems of Drug Dependence.

“Thanks to the app, there may have been a life saved about twice a month that otherwise wouldn’t have been,” said public health researcher and study coauthor Stephen Lankenau, PhD, of Drexel University, Philadelphia, in an interview.

Philadelphia has the largest opioid overdose rate of any large city, Dr. Lankenau said, and people who overdose are often reluctant to call 911. “Police are often alerted when it’s determined that it’s a drug-related call. They’re concerned that police could show up and someone will get arrested.”

However, the app, called UnityPhilly, doesn’t remove professional medics from the picture. It’s designed to be a supplement to the existing first-response system – “it’s not meant to replace 911” – and allow a faster response to overdoses when minutes matter, Dr. Lankenau said.

“If someone is adamantly opposed to calling 911,” he said, “this may not be the best intervention for them.”

Here’s how the app works: Participants who overdose themselves or witness an overdose can send out an alert to nearby app users. When an alert goes out, the app also attempts to dial 911, although the participant can bypass this.

Nearby responders can reply by pressing “En route” and then go to the address of the overdose with a provided supply of naloxone (Narcan). The amateur responders, many of whom are or were opioid users themselves, are trained in how to administer the drug.

The study authors recruited 112 participants from the Philadelphia neighborhood of Kensington and tracked them from 2019 to 2020. About half (n = 57) reported using opioids within the past 30 days, and those participants had an average age of 42 years, were 54% men, and were 74% non-Hispanic white. Only 19% were employed, and 42% had been recently homeless. Nearly 80% had overdosed before, and all had witnessed overdoses.

The other participants (n = 55), defined as “community members,” had less experience with opioids (44% had misused them before), although 91% had witnessed overdoses. Their average age was 42 years, 56% were women, 53% were employed, and 16% had been recently homeless.

Over a 1-year period, 51% of the opioid-using participants used the app to report an overdose, as did 46% of the community members. The percentages who reported being en route to an overdose was 47% (opioid users) and 46% (community members).

“The idea of people being trained as community responders has been around for quite a while, and there are hundreds of programs across the country. People are willing to carry naloxone and respond if they see an overdose in front of them,” Dr. Lankenau said. “Here, you have people becoming civilian responders to events they wouldn’t otherwise know about. This creates a community of individuals who can help out immediately and augment the work that emergency responders do.”

Opioid users who download the app may be drawn to the idea of responders who are nonjudgmental and supportive, compared with professional medics. “The system has not done well by people with substance abuse disorders,” said addiction medicine specialist Sukhpreet Klaire, MD, of the British Columbia Center on Substance Use in Vancouver. “In terms of overdose reversal, you may prefer that someone else [other than a medic] give you Narcan and support you through this experience. When it’s over after you’re reversed, you have a sudden onset of withdrawal symptoms. You feel terrible, and you don’t want to be sitting in an ambulance. You want to be in a supportive environment.”

As for adverse effects, there was concern that opioid users might take more risks with an app safety net in place. However, no one reported more risky behavior in interviews, Dr. Lankenau said.

The 3-year program costs $215,000, he said, and the next step is to get funding for a Philadelphia citywide trial.

The study was funded by the National Institute of Drug Abuse. Dr. Lankenau reported no relevant disclosures. Dr. Klaire disclosed participating in a research fellowship and a research in addiction medical scholars program, both funded by NIDA.

Age-adjusted infant mortality dropped 11% from 2000 to 2017 in the United States, but the even larger decline for infants born to black women still left a death rate more than twice as high as those of white or Hispanic infants, according to a new analysis from the National Center for Health Statistics.

Overall maternal age–adjusted infant mortality decreased 11% from 6.89 per 1,000 births in 2000 to 6.13 per 1,000 in 2017, while the crude mortality rate fell 16% from 6.89 to 5.79, reported Anne K. Driscoll, PhD, and Danielle M. Ely, PhD, of the NCHS.

Over that same time period, age-adjusted infant mortality for births to black women went from 13.59 per 1,000 to 11.19, a drop of 18%. By comparison, age-adjusted mortality declined 7% from 5.59 per 1,000 for infants born to Hispanic women to 5.21 in 2017, they said in a National Vital Statistics Report.

Changes in maternal age distribution had an important effect on infant mortality. Women aged under 25 years, who have higher mortality rates, were less likely to give birth in 2017 than in 2000, and women aged 30-39 years, who have the lowest rates, made up a larger share of births in 2017, they pointed out.

It was, however, changes in age-specific mortality rates (ASMRs) that had the largest influence on the overall drop in the crude mortality rate, accounting for about two-thirds of the overall decline, the NCHS researchers said, noting that the effect varied by race and Hispanic origin.

Births to non-Hispanic white women mirrored the national situation: Approximately two-thirds (68.7%) of the decrease in infant mortality came from changes in ASMRs and one-third (31.3%) from changes in maternal age distribution. Among non-Hispanic black women, the distribution was 95.2% ASMRs and 4.8% age distribution, Dr. Driscoll and Dr. Ely reported based on data from the National Vital Statistics System.

The disparity between the two trends went even further for infants born to Hispanic women. Changes in ASMRs were responsible for 133.7% of the overall change in crude mortality versus –33.7% for changes in maternal age distribution. “If no changes occurred in the ASMRs, the changes in the maternal age distribution would have resulted in a higher mortality rate in 2017,” they explained.

The declines in the ASMRs may be related to incremental improved survival of preterm and low-birthweight infants in certain groups. “While little or no progress has been made to lower [these] two key risk factors for poor birth outcomes, progress has been made in lowering the mortality rates of at-risk infants across maternal age and race and Hispanic origin, resulting in lower ASMRs for all age groups,” the investigators suggested.

It also is possible that “changes in other factors, such as maternal education and cigarette smoking during pregnancy, may have indirectly resulted in declining ASMRs for all age groups over time,” they added.

rfranki@mdedge.com

SOURCE: Driscoll AK, Ely DM. National Vital Statistics Reports. 2020;69(5):1-18.

Age-adjusted infant mortality dropped 11% from 2000 to 2017 in the United States, but the even larger decline for infants born to black women still left a death rate more than twice as high as those of white or Hispanic infants, according to a new analysis from the National Center for Health Statistics.

Overall maternal age–adjusted infant mortality decreased 11% from 6.89 per 1,000 births in 2000 to 6.13 per 1,000 in 2017, while the crude mortality rate fell 16% from 6.89 to 5.79, reported Anne K. Driscoll, PhD, and Danielle M. Ely, PhD, of the NCHS.

Over that same time period, age-adjusted infant mortality for births to black women went from 13.59 per 1,000 to 11.19, a drop of 18%. By comparison, age-adjusted mortality declined 7% from 5.59 per 1,000 for infants born to Hispanic women to 5.21 in 2017, they said in a National Vital Statistics Report.

Changes in maternal age distribution had an important effect on infant mortality. Women aged under 25 years, who have higher mortality rates, were less likely to give birth in 2017 than in 2000, and women aged 30-39 years, who have the lowest rates, made up a larger share of births in 2017, they pointed out.

It was, however, changes in age-specific mortality rates (ASMRs) that had the largest influence on the overall drop in the crude mortality rate, accounting for about two-thirds of the overall decline, the NCHS researchers said, noting that the effect varied by race and Hispanic origin.

Births to non-Hispanic white women mirrored the national situation: Approximately two-thirds (68.7%) of the decrease in infant mortality came from changes in ASMRs and one-third (31.3%) from changes in maternal age distribution. Among non-Hispanic black women, the distribution was 95.2% ASMRs and 4.8% age distribution, Dr. Driscoll and Dr. Ely reported based on data from the National Vital Statistics System.

The disparity between the two trends went even further for infants born to Hispanic women. Changes in ASMRs were responsible for 133.7% of the overall change in crude mortality versus –33.7% for changes in maternal age distribution. “If no changes occurred in the ASMRs, the changes in the maternal age distribution would have resulted in a higher mortality rate in 2017,” they explained.

The declines in the ASMRs may be related to incremental improved survival of preterm and low-birthweight infants in certain groups. “While little or no progress has been made to lower [these] two key risk factors for poor birth outcomes, progress has been made in lowering the mortality rates of at-risk infants across maternal age and race and Hispanic origin, resulting in lower ASMRs for all age groups,” the investigators suggested.

It also is possible that “changes in other factors, such as maternal education and cigarette smoking during pregnancy, may have indirectly resulted in declining ASMRs for all age groups over time,” they added.

rfranki@mdedge.com

SOURCE: Driscoll AK, Ely DM. National Vital Statistics Reports. 2020;69(5):1-18.

Age-adjusted infant mortality dropped 11% from 2000 to 2017 in the United States, but the even larger decline for infants born to black women still left a death rate more than twice as high as those of white or Hispanic infants, according to a new analysis from the National Center for Health Statistics.

Overall maternal age–adjusted infant mortality decreased 11% from 6.89 per 1,000 births in 2000 to 6.13 per 1,000 in 2017, while the crude mortality rate fell 16% from 6.89 to 5.79, reported Anne K. Driscoll, PhD, and Danielle M. Ely, PhD, of the NCHS.

Over that same time period, age-adjusted infant mortality for births to black women went from 13.59 per 1,000 to 11.19, a drop of 18%. By comparison, age-adjusted mortality declined 7% from 5.59 per 1,000 for infants born to Hispanic women to 5.21 in 2017, they said in a National Vital Statistics Report.

Changes in maternal age distribution had an important effect on infant mortality. Women aged under 25 years, who have higher mortality rates, were less likely to give birth in 2017 than in 2000, and women aged 30-39 years, who have the lowest rates, made up a larger share of births in 2017, they pointed out.

It was, however, changes in age-specific mortality rates (ASMRs) that had the largest influence on the overall drop in the crude mortality rate, accounting for about two-thirds of the overall decline, the NCHS researchers said, noting that the effect varied by race and Hispanic origin.

Births to non-Hispanic white women mirrored the national situation: Approximately two-thirds (68.7%) of the decrease in infant mortality came from changes in ASMRs and one-third (31.3%) from changes in maternal age distribution. Among non-Hispanic black women, the distribution was 95.2% ASMRs and 4.8% age distribution, Dr. Driscoll and Dr. Ely reported based on data from the National Vital Statistics System.

The disparity between the two trends went even further for infants born to Hispanic women. Changes in ASMRs were responsible for 133.7% of the overall change in crude mortality versus –33.7% for changes in maternal age distribution. “If no changes occurred in the ASMRs, the changes in the maternal age distribution would have resulted in a higher mortality rate in 2017,” they explained.

The declines in the ASMRs may be related to incremental improved survival of preterm and low-birthweight infants in certain groups. “While little or no progress has been made to lower [these] two key risk factors for poor birth outcomes, progress has been made in lowering the mortality rates of at-risk infants across maternal age and race and Hispanic origin, resulting in lower ASMRs for all age groups,” the investigators suggested.

It also is possible that “changes in other factors, such as maternal education and cigarette smoking during pregnancy, may have indirectly resulted in declining ASMRs for all age groups over time,” they added.

rfranki@mdedge.com

SOURCE: Driscoll AK, Ely DM. National Vital Statistics Reports. 2020;69(5):1-18.