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Seeking help for burnout may be a gamble for doctors
By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.
Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.
There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.
Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.
Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.
“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.
He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.
“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”
The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.
Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
A plea for help
In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”
Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.
But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.
Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.
After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.
Five days later, his job offer was revoked.
In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.
The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”
Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.
“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.
Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.
“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”
“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.
Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.”
Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
Current state of physician burnout
The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).
A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.
Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.
“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.
Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.
Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.
“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
Helping doctors regain a sense of purpose
One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose.
“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”
Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.
“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
The road ahead
Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.
The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes.
“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.
A version of this article first appeared on Medscape.com.
By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.
Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.
There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.
Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.
Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.
“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.
He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.
“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”
The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.
Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
A plea for help
In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”
Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.
But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.
Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.
After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.
Five days later, his job offer was revoked.
In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.
The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”
Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.
“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.
Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.
“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”
“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.
Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.”
Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
Current state of physician burnout
The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).
A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.
Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.
“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.
Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.
Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.
“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
Helping doctors regain a sense of purpose
One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose.
“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”
Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.
“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
The road ahead
Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.
The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes.
“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.
A version of this article first appeared on Medscape.com.
By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.
Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.
There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.
Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.
Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.
“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.
He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.
“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”
The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.
Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
A plea for help
In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”
Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.
But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.
Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.
After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.
Five days later, his job offer was revoked.
In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.
The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”
Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.
“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.
Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.
“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”
“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.
Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.”
Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
Current state of physician burnout
The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).
A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.
Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.
“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.
Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.
Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.
“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
Helping doctors regain a sense of purpose
One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose.
“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”
Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.
“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
The road ahead
Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.
The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes.
“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.
A version of this article first appeared on Medscape.com.
Using JAK inhibitors for myelofibrosis
“We are thankfully starting to be blessed with more options than we’ve ever had,” he said, but “in the front-line proliferative setting, ruxolitinib has remained the standard of care.” It’s “well established in higher-risk patients and very much an option for very symptomatic lower-risk patients.”
Dr. Hunter helped his colleagues navigate the evolving field of JAK inhibition for myelofibrosis in a presentation titled “Choosing and Properly Using a JAK Inhibitor in Myelofibrosis,”at the Society of Hematologic Oncology annual meeting.
Ruxolitinib was the first JAK inhibitor for myelofibrosis on the U.S. market, approved in 2011. Two more have followed, fedratinib in 2019 and pacritinib in 2022.
A fourth JAK inhibitor for myelofibrosis, momelotinib, is under Food and Drug Administration review with a decision expected shortly.
JAK inhibitors disrupt a key pathogenic pathway in myelofibrosis and are a mainstay of treatment, but Dr. Hunter noted that they should not replace allogeneic transplants in patients who are candidates because transplants remain “the best way to achieve long term survival, especially in higher risk patients.”
He noted that not every patient needs a JAK inhibitor, especially “lower-risk, more asymptomatic patients who are predominantly manifesting with cytopenias. [They] are less likely to benefit.”
Dr. Hunter said that although ruxolitinib remains a treatment of choice, fedratinib “is certainly an option” with comparable rates of symptom control and splenomegaly reduction. Also, while ruxolitinib is dosed according to platelet levels, fedratinib allows for full dosing down to a platelet count of 50 x 109/L.
“But there’s more GI toxicity than with ruxolitinib, especially in the first couple of months,” he said, as well as a black box warning of Wernicke’s encephalopathy. “I generally put all my [fedratinib] patients on thiamine repletion as a precaution.”
One of the most challenging aspects of using JAK inhibitors for myelofibrosis is their tendency to cause cytopenia, particularly anemia and thrombocytopenia, which, ironically, are also hallmarks of myelofibrosis itself.
Although there’s an alternative low-dose ruxolitinib regimen that can be effective in anemic settings, the approval of pacritinib and most likely momelotinib is particularly helpful for cytopenic patients, “a population which historically has been very hard to treat with our prior agents,” Dr. Hunter said.
Pacritinib is approved specifically for patients with platelet counts below 50 x 109/L; momelotinib also included lower platelet counts in several studies. Both agents indirectly boost erythropoiesis with subsequent amelioration of anemia.
“Momelotinib is an important emerging agent for these more anemic patients,” with a spleen response comparable to ruxolitinib and significantly higher rates of transfusion independence, but with lower rates of symptom control, Dr. Hunter said.
Pacritinib “really helps extend the benefit of JAK inhibitors to a group of thrombocytopenic patients who have been hard to treat with ruxolitinib,” with the added potential of improving anemia, although, like fedratinib, it has more GI toxicity, he said.
There are multiple add-on options for JAK inhibitor patients with anemia, including luspatercept, an erythropoiesis-stimulating agent approved for anemia in patients with myelodysplastic syndromes; promising results were reported recently for myelofibrosis.
Fedratinib, pacritinib, and momelotinib all have activity in the second line after ruxolitinib failure, Dr. Hunter noted, but he cautioned that ruxolitinib must be tapered over a few weeks, not stopped abruptly, to avoid withdrawal symptoms. Some clinicians overlap JAK inhibitors a day or two to avoid issues.
“Clinical trials should still be considered in many of these settings,” he said, adding that emerging agents are under development, including multiple combination therapies, often with JAK inhibitors as the background.
No disclosure information was reported.
“We are thankfully starting to be blessed with more options than we’ve ever had,” he said, but “in the front-line proliferative setting, ruxolitinib has remained the standard of care.” It’s “well established in higher-risk patients and very much an option for very symptomatic lower-risk patients.”
Dr. Hunter helped his colleagues navigate the evolving field of JAK inhibition for myelofibrosis in a presentation titled “Choosing and Properly Using a JAK Inhibitor in Myelofibrosis,”at the Society of Hematologic Oncology annual meeting.
Ruxolitinib was the first JAK inhibitor for myelofibrosis on the U.S. market, approved in 2011. Two more have followed, fedratinib in 2019 and pacritinib in 2022.
A fourth JAK inhibitor for myelofibrosis, momelotinib, is under Food and Drug Administration review with a decision expected shortly.
JAK inhibitors disrupt a key pathogenic pathway in myelofibrosis and are a mainstay of treatment, but Dr. Hunter noted that they should not replace allogeneic transplants in patients who are candidates because transplants remain “the best way to achieve long term survival, especially in higher risk patients.”
He noted that not every patient needs a JAK inhibitor, especially “lower-risk, more asymptomatic patients who are predominantly manifesting with cytopenias. [They] are less likely to benefit.”
Dr. Hunter said that although ruxolitinib remains a treatment of choice, fedratinib “is certainly an option” with comparable rates of symptom control and splenomegaly reduction. Also, while ruxolitinib is dosed according to platelet levels, fedratinib allows for full dosing down to a platelet count of 50 x 109/L.
“But there’s more GI toxicity than with ruxolitinib, especially in the first couple of months,” he said, as well as a black box warning of Wernicke’s encephalopathy. “I generally put all my [fedratinib] patients on thiamine repletion as a precaution.”
One of the most challenging aspects of using JAK inhibitors for myelofibrosis is their tendency to cause cytopenia, particularly anemia and thrombocytopenia, which, ironically, are also hallmarks of myelofibrosis itself.
Although there’s an alternative low-dose ruxolitinib regimen that can be effective in anemic settings, the approval of pacritinib and most likely momelotinib is particularly helpful for cytopenic patients, “a population which historically has been very hard to treat with our prior agents,” Dr. Hunter said.
Pacritinib is approved specifically for patients with platelet counts below 50 x 109/L; momelotinib also included lower platelet counts in several studies. Both agents indirectly boost erythropoiesis with subsequent amelioration of anemia.
“Momelotinib is an important emerging agent for these more anemic patients,” with a spleen response comparable to ruxolitinib and significantly higher rates of transfusion independence, but with lower rates of symptom control, Dr. Hunter said.
Pacritinib “really helps extend the benefit of JAK inhibitors to a group of thrombocytopenic patients who have been hard to treat with ruxolitinib,” with the added potential of improving anemia, although, like fedratinib, it has more GI toxicity, he said.
There are multiple add-on options for JAK inhibitor patients with anemia, including luspatercept, an erythropoiesis-stimulating agent approved for anemia in patients with myelodysplastic syndromes; promising results were reported recently for myelofibrosis.
Fedratinib, pacritinib, and momelotinib all have activity in the second line after ruxolitinib failure, Dr. Hunter noted, but he cautioned that ruxolitinib must be tapered over a few weeks, not stopped abruptly, to avoid withdrawal symptoms. Some clinicians overlap JAK inhibitors a day or two to avoid issues.
“Clinical trials should still be considered in many of these settings,” he said, adding that emerging agents are under development, including multiple combination therapies, often with JAK inhibitors as the background.
No disclosure information was reported.
“We are thankfully starting to be blessed with more options than we’ve ever had,” he said, but “in the front-line proliferative setting, ruxolitinib has remained the standard of care.” It’s “well established in higher-risk patients and very much an option for very symptomatic lower-risk patients.”
Dr. Hunter helped his colleagues navigate the evolving field of JAK inhibition for myelofibrosis in a presentation titled “Choosing and Properly Using a JAK Inhibitor in Myelofibrosis,”at the Society of Hematologic Oncology annual meeting.
Ruxolitinib was the first JAK inhibitor for myelofibrosis on the U.S. market, approved in 2011. Two more have followed, fedratinib in 2019 and pacritinib in 2022.
A fourth JAK inhibitor for myelofibrosis, momelotinib, is under Food and Drug Administration review with a decision expected shortly.
JAK inhibitors disrupt a key pathogenic pathway in myelofibrosis and are a mainstay of treatment, but Dr. Hunter noted that they should not replace allogeneic transplants in patients who are candidates because transplants remain “the best way to achieve long term survival, especially in higher risk patients.”
He noted that not every patient needs a JAK inhibitor, especially “lower-risk, more asymptomatic patients who are predominantly manifesting with cytopenias. [They] are less likely to benefit.”
Dr. Hunter said that although ruxolitinib remains a treatment of choice, fedratinib “is certainly an option” with comparable rates of symptom control and splenomegaly reduction. Also, while ruxolitinib is dosed according to platelet levels, fedratinib allows for full dosing down to a platelet count of 50 x 109/L.
“But there’s more GI toxicity than with ruxolitinib, especially in the first couple of months,” he said, as well as a black box warning of Wernicke’s encephalopathy. “I generally put all my [fedratinib] patients on thiamine repletion as a precaution.”
One of the most challenging aspects of using JAK inhibitors for myelofibrosis is their tendency to cause cytopenia, particularly anemia and thrombocytopenia, which, ironically, are also hallmarks of myelofibrosis itself.
Although there’s an alternative low-dose ruxolitinib regimen that can be effective in anemic settings, the approval of pacritinib and most likely momelotinib is particularly helpful for cytopenic patients, “a population which historically has been very hard to treat with our prior agents,” Dr. Hunter said.
Pacritinib is approved specifically for patients with platelet counts below 50 x 109/L; momelotinib also included lower platelet counts in several studies. Both agents indirectly boost erythropoiesis with subsequent amelioration of anemia.
“Momelotinib is an important emerging agent for these more anemic patients,” with a spleen response comparable to ruxolitinib and significantly higher rates of transfusion independence, but with lower rates of symptom control, Dr. Hunter said.
Pacritinib “really helps extend the benefit of JAK inhibitors to a group of thrombocytopenic patients who have been hard to treat with ruxolitinib,” with the added potential of improving anemia, although, like fedratinib, it has more GI toxicity, he said.
There are multiple add-on options for JAK inhibitor patients with anemia, including luspatercept, an erythropoiesis-stimulating agent approved for anemia in patients with myelodysplastic syndromes; promising results were reported recently for myelofibrosis.
Fedratinib, pacritinib, and momelotinib all have activity in the second line after ruxolitinib failure, Dr. Hunter noted, but he cautioned that ruxolitinib must be tapered over a few weeks, not stopped abruptly, to avoid withdrawal symptoms. Some clinicians overlap JAK inhibitors a day or two to avoid issues.
“Clinical trials should still be considered in many of these settings,” he said, adding that emerging agents are under development, including multiple combination therapies, often with JAK inhibitors as the background.
No disclosure information was reported.
FROM SOHO 2023
Environmental and occupational risk factors for lung cancer
Thoracic Oncology And Chest Imaging Network
Lung Cancer Section
Lung cancer is the third most prevalent cancer in United States, with the highest mortality (Oliver, 2022)(Siegel et al, 2023). The factors contributing to its occurrence have become more complex due to increased industrialization and worsening environmental pollution. Air pollution is a well-established environmental risk factor for lung cancer (Lu et al. 2019). On average, a full-time worker spends around 90,000 hours at work over their lifetime. It is crucial to control environmental and occupational exposures to decrease the risk of developing lung cancer. Occupations like asbestos-related work, mining, and transportation are well-known to be at risk for lung cancer (Li et al. 2021). With worsening air pollution, occupations such as firefighters, outdoor delivery workers, and forest rangers are facing an increased risk as well. Many of these carcinogens independently increase lung cancer risk (Li et al. 2021). Smoking combined with these exposures, causes a synergistic effect on lung cancer incidence. They also have a cell subtype differential risk favoring squamous and small cell lung cancer (Christiani, 2020). It is essential for workers in these high-risk occupations to use proper PPE, have regular check-ups and screenings and follow occupational safety regulations and guidelines. As air pollution continues to worsen, individuals living in these areas should reduce outdoor activities during AQI alerts, and use air purifiers and masks. Public health efforts to decrease air pollution with cleaner transportation and energy production, and better local and national air quality regulations will decrease risk in the general population (Rice et al. 2021).
Amaraja Kanitkar, MD, MBBSGuest Author
References
Christiani DC. Occupational exposures and lung cancer. Am J Respir Crit Care Med. 2020;202(3):317-19.
Li N, et al. Association of 13 occupational carcinogens in patients with cancer, individually and collectively, 1990-2017. JAMA Netw Open. 2021;4(2):e2037530.
Lu T, et al. Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades. Cancer Manag Res. 2019;11:943-53.
Oliver AL. Lung cancer: Epidemiology and screening. Surg Clin North Am. 2022;102(3):335-44.
Rice MB, et al. Respiratory impacts of wildland fire smoke: Future challenges and policy opportunities an official American thoracic society workshop report. Ann Am Thorac Soc. 2021;18(6):921-30.
Siegel RL, et al. Cancer statistics: 2023. CA Cancer J Clin. 2023;73(1):17-48.
Thoracic Oncology And Chest Imaging Network
Lung Cancer Section
Lung cancer is the third most prevalent cancer in United States, with the highest mortality (Oliver, 2022)(Siegel et al, 2023). The factors contributing to its occurrence have become more complex due to increased industrialization and worsening environmental pollution. Air pollution is a well-established environmental risk factor for lung cancer (Lu et al. 2019). On average, a full-time worker spends around 90,000 hours at work over their lifetime. It is crucial to control environmental and occupational exposures to decrease the risk of developing lung cancer. Occupations like asbestos-related work, mining, and transportation are well-known to be at risk for lung cancer (Li et al. 2021). With worsening air pollution, occupations such as firefighters, outdoor delivery workers, and forest rangers are facing an increased risk as well. Many of these carcinogens independently increase lung cancer risk (Li et al. 2021). Smoking combined with these exposures, causes a synergistic effect on lung cancer incidence. They also have a cell subtype differential risk favoring squamous and small cell lung cancer (Christiani, 2020). It is essential for workers in these high-risk occupations to use proper PPE, have regular check-ups and screenings and follow occupational safety regulations and guidelines. As air pollution continues to worsen, individuals living in these areas should reduce outdoor activities during AQI alerts, and use air purifiers and masks. Public health efforts to decrease air pollution with cleaner transportation and energy production, and better local and national air quality regulations will decrease risk in the general population (Rice et al. 2021).
Amaraja Kanitkar, MD, MBBSGuest Author
References
Christiani DC. Occupational exposures and lung cancer. Am J Respir Crit Care Med. 2020;202(3):317-19.
Li N, et al. Association of 13 occupational carcinogens in patients with cancer, individually and collectively, 1990-2017. JAMA Netw Open. 2021;4(2):e2037530.
Lu T, et al. Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades. Cancer Manag Res. 2019;11:943-53.
Oliver AL. Lung cancer: Epidemiology and screening. Surg Clin North Am. 2022;102(3):335-44.
Rice MB, et al. Respiratory impacts of wildland fire smoke: Future challenges and policy opportunities an official American thoracic society workshop report. Ann Am Thorac Soc. 2021;18(6):921-30.
Siegel RL, et al. Cancer statistics: 2023. CA Cancer J Clin. 2023;73(1):17-48.
Thoracic Oncology And Chest Imaging Network
Lung Cancer Section
Lung cancer is the third most prevalent cancer in United States, with the highest mortality (Oliver, 2022)(Siegel et al, 2023). The factors contributing to its occurrence have become more complex due to increased industrialization and worsening environmental pollution. Air pollution is a well-established environmental risk factor for lung cancer (Lu et al. 2019). On average, a full-time worker spends around 90,000 hours at work over their lifetime. It is crucial to control environmental and occupational exposures to decrease the risk of developing lung cancer. Occupations like asbestos-related work, mining, and transportation are well-known to be at risk for lung cancer (Li et al. 2021). With worsening air pollution, occupations such as firefighters, outdoor delivery workers, and forest rangers are facing an increased risk as well. Many of these carcinogens independently increase lung cancer risk (Li et al. 2021). Smoking combined with these exposures, causes a synergistic effect on lung cancer incidence. They also have a cell subtype differential risk favoring squamous and small cell lung cancer (Christiani, 2020). It is essential for workers in these high-risk occupations to use proper PPE, have regular check-ups and screenings and follow occupational safety regulations and guidelines. As air pollution continues to worsen, individuals living in these areas should reduce outdoor activities during AQI alerts, and use air purifiers and masks. Public health efforts to decrease air pollution with cleaner transportation and energy production, and better local and national air quality regulations will decrease risk in the general population (Rice et al. 2021).
Amaraja Kanitkar, MD, MBBSGuest Author
References
Christiani DC. Occupational exposures and lung cancer. Am J Respir Crit Care Med. 2020;202(3):317-19.
Li N, et al. Association of 13 occupational carcinogens in patients with cancer, individually and collectively, 1990-2017. JAMA Netw Open. 2021;4(2):e2037530.
Lu T, et al. Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades. Cancer Manag Res. 2019;11:943-53.
Oliver AL. Lung cancer: Epidemiology and screening. Surg Clin North Am. 2022;102(3):335-44.
Rice MB, et al. Respiratory impacts of wildland fire smoke: Future challenges and policy opportunities an official American thoracic society workshop report. Ann Am Thorac Soc. 2021;18(6):921-30.
Siegel RL, et al. Cancer statistics: 2023. CA Cancer J Clin. 2023;73(1):17-48.
PalliPulm: Time to expand our arsenal
Critical Care Network
Palliative and End-of-Life Section
Symptoms at the end of life in patients with COPD are just as severe as in patients with advanced cancer (Solano JP, et al. J Pain Symptom Manage. 2006;31[1]:58-69). However, despite the high symptom burden, palliative care is less common in patients with COPD (Gore J, et al. Thorax. 2000;55[12]:1000-6).
Palliative care is associated with a number of benefits, including improved symptom burden, quality of life, and patient satisfaction (Vermylen JH, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:1543-51). The majority of pulmonologists report that palliative care for patients with COPD is desirable, but about half of pulmonologists indicate that they do not use the palliative care guidelines and many were not even aware they existed (Duenk RG, et al. Int J Chron Obstruct Pulmon Dis. 2017;12:299-311). Patients with COPD often have unmet needs, and the majority of patients with COPD do not have access to palliative care at their end of life (Gore JM, et al). Unfortunately, the supply of palliative care specialists is too low to meet demand, especially in outpatient settings (Kamal AH, et al. Am J Med. 2017;130:113-4).
The ATS released a multisociety policy statement in 2022 that established a framework for early palliative care in the care in patients with respiratory illnesses (Sullivan DR, et al. Am J Respir Crit Care Med. 2022;206[6]:e44-e69). However, given the paucity of specialists and the aging population, the needs of patients and their loved ones cannot be met exclusively by palliative care specialists. Pulmonologists must expand their practice to include guideline-based palliative care in order to truly serve our patients to the best of our abilities. It is incumbent on training programs to train future pulmonologists with these palliative skills, and upon medical organizations to supply time and resources to ensure the pulmonologist is able to use these skills.
Gretchen Winter, MD
Section Member-at-Large
Critical Care Network
Palliative and End-of-Life Section
Symptoms at the end of life in patients with COPD are just as severe as in patients with advanced cancer (Solano JP, et al. J Pain Symptom Manage. 2006;31[1]:58-69). However, despite the high symptom burden, palliative care is less common in patients with COPD (Gore J, et al. Thorax. 2000;55[12]:1000-6).
Palliative care is associated with a number of benefits, including improved symptom burden, quality of life, and patient satisfaction (Vermylen JH, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:1543-51). The majority of pulmonologists report that palliative care for patients with COPD is desirable, but about half of pulmonologists indicate that they do not use the palliative care guidelines and many were not even aware they existed (Duenk RG, et al. Int J Chron Obstruct Pulmon Dis. 2017;12:299-311). Patients with COPD often have unmet needs, and the majority of patients with COPD do not have access to palliative care at their end of life (Gore JM, et al). Unfortunately, the supply of palliative care specialists is too low to meet demand, especially in outpatient settings (Kamal AH, et al. Am J Med. 2017;130:113-4).
The ATS released a multisociety policy statement in 2022 that established a framework for early palliative care in the care in patients with respiratory illnesses (Sullivan DR, et al. Am J Respir Crit Care Med. 2022;206[6]:e44-e69). However, given the paucity of specialists and the aging population, the needs of patients and their loved ones cannot be met exclusively by palliative care specialists. Pulmonologists must expand their practice to include guideline-based palliative care in order to truly serve our patients to the best of our abilities. It is incumbent on training programs to train future pulmonologists with these palliative skills, and upon medical organizations to supply time and resources to ensure the pulmonologist is able to use these skills.
Gretchen Winter, MD
Section Member-at-Large
Critical Care Network
Palliative and End-of-Life Section
Symptoms at the end of life in patients with COPD are just as severe as in patients with advanced cancer (Solano JP, et al. J Pain Symptom Manage. 2006;31[1]:58-69). However, despite the high symptom burden, palliative care is less common in patients with COPD (Gore J, et al. Thorax. 2000;55[12]:1000-6).
Palliative care is associated with a number of benefits, including improved symptom burden, quality of life, and patient satisfaction (Vermylen JH, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:1543-51). The majority of pulmonologists report that palliative care for patients with COPD is desirable, but about half of pulmonologists indicate that they do not use the palliative care guidelines and many were not even aware they existed (Duenk RG, et al. Int J Chron Obstruct Pulmon Dis. 2017;12:299-311). Patients with COPD often have unmet needs, and the majority of patients with COPD do not have access to palliative care at their end of life (Gore JM, et al). Unfortunately, the supply of palliative care specialists is too low to meet demand, especially in outpatient settings (Kamal AH, et al. Am J Med. 2017;130:113-4).
The ATS released a multisociety policy statement in 2022 that established a framework for early palliative care in the care in patients with respiratory illnesses (Sullivan DR, et al. Am J Respir Crit Care Med. 2022;206[6]:e44-e69). However, given the paucity of specialists and the aging population, the needs of patients and their loved ones cannot be met exclusively by palliative care specialists. Pulmonologists must expand their practice to include guideline-based palliative care in order to truly serve our patients to the best of our abilities. It is incumbent on training programs to train future pulmonologists with these palliative skills, and upon medical organizations to supply time and resources to ensure the pulmonologist is able to use these skills.
Gretchen Winter, MD
Section Member-at-Large
Hot or cold – impact on asthma and COPD
Airways Disorders Network
Asthma & COPD Section
Earlier works investigating effects of temperature and humidity changes on the airway in patients with asthma are insightful (Strauss, et al. 1978). Heat can irritate asthmatic airways that are already hyperreactive. Cold air can remove airway moisture. Similar mechanisms with warm/hot air can affect airway inflammation in COPD. In addition, poor air quality often occurs during extreme heat events and can affect patients with COPD.
Seasonal variation in COPD exacerbations was demonstrated by the TORCH study, where a two-fold increase in COPD exacerbations and hospitalizations was noted during the winter months in both northern and southern regions of the world. This trend was not observed in tropical countries with average annual temperatures of >18 °C (64 °F). Factors accounting for this variation may include greater risk of viral infections, increased host susceptibility, and more time spent indoors, along with impact of temperature variation on lung function (Jenkins, et al. 2012). This effect was accompanied by variation in the treatment choices with antibiotics alone or in combination with steroids. A trend towards combined antibiotics and steroids was noted during winters.
Ideal conditions for patients with COPD to minimize risk for exacerbation would be home humidity between 30% and 50% with indoor temperature of 21°C at least 9 hours per day in living areas (Osman, et al. 2008).
Outdoor activities during extreme temperatures should be avoided. Air conditioning and/or humidifiers can be helpful in modifying influences.
Maria Azhar, MD
Section Fellow-in-Training
Richard George Barbers, MD, FCCP
Section Chair
References
Jenkins CR, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012;39(1):38-45.
Osman LM, et al. Home warmth and health status of COPD patients. Eur J Public Health. 2008;18(4):399-405.
Strauss RH, et al. Influence of heat and humidity on the airway obstruction induced by exercise in asthma. J Clin Invest. 1978;61(2):433-40.
Airways Disorders Network
Asthma & COPD Section
Earlier works investigating effects of temperature and humidity changes on the airway in patients with asthma are insightful (Strauss, et al. 1978). Heat can irritate asthmatic airways that are already hyperreactive. Cold air can remove airway moisture. Similar mechanisms with warm/hot air can affect airway inflammation in COPD. In addition, poor air quality often occurs during extreme heat events and can affect patients with COPD.
Seasonal variation in COPD exacerbations was demonstrated by the TORCH study, where a two-fold increase in COPD exacerbations and hospitalizations was noted during the winter months in both northern and southern regions of the world. This trend was not observed in tropical countries with average annual temperatures of >18 °C (64 °F). Factors accounting for this variation may include greater risk of viral infections, increased host susceptibility, and more time spent indoors, along with impact of temperature variation on lung function (Jenkins, et al. 2012). This effect was accompanied by variation in the treatment choices with antibiotics alone or in combination with steroids. A trend towards combined antibiotics and steroids was noted during winters.
Ideal conditions for patients with COPD to minimize risk for exacerbation would be home humidity between 30% and 50% with indoor temperature of 21°C at least 9 hours per day in living areas (Osman, et al. 2008).
Outdoor activities during extreme temperatures should be avoided. Air conditioning and/or humidifiers can be helpful in modifying influences.
Maria Azhar, MD
Section Fellow-in-Training
Richard George Barbers, MD, FCCP
Section Chair
References
Jenkins CR, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012;39(1):38-45.
Osman LM, et al. Home warmth and health status of COPD patients. Eur J Public Health. 2008;18(4):399-405.
Strauss RH, et al. Influence of heat and humidity on the airway obstruction induced by exercise in asthma. J Clin Invest. 1978;61(2):433-40.
Airways Disorders Network
Asthma & COPD Section
Earlier works investigating effects of temperature and humidity changes on the airway in patients with asthma are insightful (Strauss, et al. 1978). Heat can irritate asthmatic airways that are already hyperreactive. Cold air can remove airway moisture. Similar mechanisms with warm/hot air can affect airway inflammation in COPD. In addition, poor air quality often occurs during extreme heat events and can affect patients with COPD.
Seasonal variation in COPD exacerbations was demonstrated by the TORCH study, where a two-fold increase in COPD exacerbations and hospitalizations was noted during the winter months in both northern and southern regions of the world. This trend was not observed in tropical countries with average annual temperatures of >18 °C (64 °F). Factors accounting for this variation may include greater risk of viral infections, increased host susceptibility, and more time spent indoors, along with impact of temperature variation on lung function (Jenkins, et al. 2012). This effect was accompanied by variation in the treatment choices with antibiotics alone or in combination with steroids. A trend towards combined antibiotics and steroids was noted during winters.
Ideal conditions for patients with COPD to minimize risk for exacerbation would be home humidity between 30% and 50% with indoor temperature of 21°C at least 9 hours per day in living areas (Osman, et al. 2008).
Outdoor activities during extreme temperatures should be avoided. Air conditioning and/or humidifiers can be helpful in modifying influences.
Maria Azhar, MD
Section Fellow-in-Training
Richard George Barbers, MD, FCCP
Section Chair
References
Jenkins CR, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012;39(1):38-45.
Osman LM, et al. Home warmth and health status of COPD patients. Eur J Public Health. 2008;18(4):399-405.
Strauss RH, et al. Influence of heat and humidity on the airway obstruction induced by exercise in asthma. J Clin Invest. 1978;61(2):433-40.
Implementing a hypoglossal nerve stimulation program in your sleep practice
It is estimated that almost one billion people globally are affected by obstructive sleep apnea (OSA) (Benjafield A, et al. Lancet Respir Med. 2019;7[8]:687-98). Despite such high prevalence, the treatment options for OSA are somewhat limited. As per certain estimates, nearly 50% of CPAP users discontinue treatment by the fifth year (Schoch O, et al. Respiration. 2014;87[2]:121-8). Furthermore, alternative options such as mandibular advancement devices, positional therapy, weight loss, and maxillofacial or palate surgery, also have unique challenges and limitations.
First described in 2001, hypoglossal nerve stimulation (HGNS) is a relatively new and emerging technology for the treatment of OSA (Schwartz A, et al. Arch Otolaryngol Head Neck Surg. 2001 Oct;127[10]:1216-23). HGNS therapy was approved by the Food and Drug Administration in 2014 for the treatment of moderate to severe OSA. The therapy involves surgical implantation of the HGNS device, optimization of device settings, and evaluation for treatment response. A physician-led multidisciplinary Hypoglossal Nerve Stimulation Clinic involves collaboration from essential stakeholders, most importantly sleep medicine providers, clinic staff, sleep technologists, and ENT sleep surgeons. Goals of the multidisciplinary program are to ensure timely follow-up, optimization of device settings, and maximizing treatment efficacy. This review describes steps involved in developing a successful multidisciplinary HGNS program within a sleep medicine practice.
Patient selection and evaluation
There is growing interest in HGNS relative to conventional CPAP therapy, with many patients presenting to clinic to inquire about this therapy. However, not all patients are candidates for HGNS therapy. Prioritizing appropriate patient selection and education are key first steps. The initial assessments usually occur with a sleep medicine specialist. It begins with confirmation of the diagnosis of OSA in all patients and a concerted effort to troubleshoot and address any barriers to CPAP use before consideration of surgery. Patients who are unwilling to use or unable to tolerate CPAP therapy undergo further evaluation for HGNS therapy. It is important to ensure that patients are also screened for other sleep disorders, such as insomnia or restless leg syndrome, to rule out its contribution to daytime (or nighttime) symptoms.
Other salient inclusion criteria include an apnea-hypopnea index (AHI) between 15-100 events per hour (previously 65), at least 18 years of age, and a body mass index (BMI) less than 40 kg/m2 (previously 32). Qualifying patients undergo an updated polysomnography if a recent study is not available. If the polysomnography reveals central and mixed apneas comprising less than 25 percent of the total AHI, patients are referred to ENT Sleep Surgery, and drug-induced sleep endoscopy is offered to examine upper airway anatomy. When a complete concentric collapse of the soft palate is seen on drug-induced sleep endoscopy, surgery is contraindicated. Prior palate surgery or maxillomandibular advancement (MMA) are not contraindications to HGNS therapy.
The patients receive comprehensive information on the nature of the surgery, expected recovery course, and device activation timeline. Perhaps most importantly, the patients receive structured education on HGNS therapy and potential outcomes to set realistic expectations. In the STAR trial, patients experienced a reduction in the AHI of approximately 70% (Strollo P, et al. N Engl J Med. 2014;370[2]:139-49). It is important to note that a response to therapy was defined as a reduction in the AHI by at least 50% and a value less than 20 events/hour (Strollo P, et al. Sleep. 2015;38[10]:1593-8). Therefore, patients who are expecting complete resolution of snoring and/or OSA may not be ideal candidates for surgery. Furthermore, patients who continue to experience fatigue and sleepiness on CPAP despite control of OSA may not experience amelioration of these symptoms with HGNS therapy.
Surgery and device management
The surgery, performed under general anesthesia, lasts approximately 3 hours, and may be followed by an overnight hospital stay depending on patient’s comorbidities. The device implantation involves placement of an implantable pulse generator (IPG) in the chest wall and leads to the hypoglossal nerve. The IPG is similar to a pacemaker and functions to stimulate the ipsilateral hypoglossal nerve innervating the tongue during sleep. The most common postoperative complications noted in the STAR trial data include incision site pain and swelling as well as temporary tongue weakness or paresthesia. Postoperative restrictions are minimal and include no heavy lifting for one month after surgery.
One week postsurgery, patients return to the ENT Sleep Surgery Clinic for follow-up, at which time the incisions as well as tongue strength and sensation are evaluated. In a subsequent visit between 4 and 6 weeks postsurgery, patients are evaluated in a joint Sleep Medicine and ENT clinic. They undergo device education and activation of the IPG using a dedicated programmer obtained from the device manufacturer. Device comfort features such as start delay and pause time are also programmed. Furthermore, appropriate tongue movement, lead placement, and voltage range settings are assessed during the visit. The ENT surgery team reevaluates the incision sites and assesses for tongue function and sensation. Patients are instructed to increase the voltage incrementally every week as tolerated with the goal of using the device nightly for the entirety of sleep. If patients tolerate the therapy well during the 2- to 3-month follow-up, a sleep study is scheduled to evaluate treatment effectiveness at the peak tolerable voltage. For those struggling with the therapy, adjustments to electrode configurations should be considered for pulse width, and rate. Occasionally, patients may require awake endoscopy and/or an advanced HGNS titration while asleep to determine the most appropriate settings to optimally control sleep apnea.
Until recently, patients implanted with an early version of the HGNS were limited to magnetic resonance imaging (MRI) scans of the head, neck, and extremities only. However, patients with the latest model IPGs can now undergo full-body MRI scans. It is important to note that the MRI’s Tesla cannot exceed 1.5T, necessitating specific imaging centers. Other constraints include the inability to adjust device settings remotely, which could mean long travel for minor setting adjustments such as altering start delay or pause times. Furthermore, provider education on operating and managing the device can be time consuming and may also be a barrier to implementation in a clinic. Also challenging may be the availability of an ENT surgery, which plays a critical role in the implantation of the devices and follow-up.
Currently, Inspire Medical Systems is the only FDA-approved hypoglossal nerve stimulation device available in the United States, and globally, more than 45,000 patients have been implanted. However, the field of neurostimulation is rapidly growing. Companies like LivaNova have secured Investigational Device Exemption for their HGNS device. The Genio system by Nyxoah is evaluating the use of bilateral hypoglossal nerve stimulation in patients with OSA and complete concentric collapse of the palate. A multidisciplinary Hypoglossal Nerve Stimulation Clinic is an important component of a comprehensive sleep medicine clinic for patient care and medical education. In the appropriate patient, this emerging technology may provide improvement in OSA severity and symptoms.
Dr. Gill is Clinical Associate Professor, Division of Sleep Medicine, Stanford (Calif.) University.
It is estimated that almost one billion people globally are affected by obstructive sleep apnea (OSA) (Benjafield A, et al. Lancet Respir Med. 2019;7[8]:687-98). Despite such high prevalence, the treatment options for OSA are somewhat limited. As per certain estimates, nearly 50% of CPAP users discontinue treatment by the fifth year (Schoch O, et al. Respiration. 2014;87[2]:121-8). Furthermore, alternative options such as mandibular advancement devices, positional therapy, weight loss, and maxillofacial or palate surgery, also have unique challenges and limitations.
First described in 2001, hypoglossal nerve stimulation (HGNS) is a relatively new and emerging technology for the treatment of OSA (Schwartz A, et al. Arch Otolaryngol Head Neck Surg. 2001 Oct;127[10]:1216-23). HGNS therapy was approved by the Food and Drug Administration in 2014 for the treatment of moderate to severe OSA. The therapy involves surgical implantation of the HGNS device, optimization of device settings, and evaluation for treatment response. A physician-led multidisciplinary Hypoglossal Nerve Stimulation Clinic involves collaboration from essential stakeholders, most importantly sleep medicine providers, clinic staff, sleep technologists, and ENT sleep surgeons. Goals of the multidisciplinary program are to ensure timely follow-up, optimization of device settings, and maximizing treatment efficacy. This review describes steps involved in developing a successful multidisciplinary HGNS program within a sleep medicine practice.
Patient selection and evaluation
There is growing interest in HGNS relative to conventional CPAP therapy, with many patients presenting to clinic to inquire about this therapy. However, not all patients are candidates for HGNS therapy. Prioritizing appropriate patient selection and education are key first steps. The initial assessments usually occur with a sleep medicine specialist. It begins with confirmation of the diagnosis of OSA in all patients and a concerted effort to troubleshoot and address any barriers to CPAP use before consideration of surgery. Patients who are unwilling to use or unable to tolerate CPAP therapy undergo further evaluation for HGNS therapy. It is important to ensure that patients are also screened for other sleep disorders, such as insomnia or restless leg syndrome, to rule out its contribution to daytime (or nighttime) symptoms.
Other salient inclusion criteria include an apnea-hypopnea index (AHI) between 15-100 events per hour (previously 65), at least 18 years of age, and a body mass index (BMI) less than 40 kg/m2 (previously 32). Qualifying patients undergo an updated polysomnography if a recent study is not available. If the polysomnography reveals central and mixed apneas comprising less than 25 percent of the total AHI, patients are referred to ENT Sleep Surgery, and drug-induced sleep endoscopy is offered to examine upper airway anatomy. When a complete concentric collapse of the soft palate is seen on drug-induced sleep endoscopy, surgery is contraindicated. Prior palate surgery or maxillomandibular advancement (MMA) are not contraindications to HGNS therapy.
The patients receive comprehensive information on the nature of the surgery, expected recovery course, and device activation timeline. Perhaps most importantly, the patients receive structured education on HGNS therapy and potential outcomes to set realistic expectations. In the STAR trial, patients experienced a reduction in the AHI of approximately 70% (Strollo P, et al. N Engl J Med. 2014;370[2]:139-49). It is important to note that a response to therapy was defined as a reduction in the AHI by at least 50% and a value less than 20 events/hour (Strollo P, et al. Sleep. 2015;38[10]:1593-8). Therefore, patients who are expecting complete resolution of snoring and/or OSA may not be ideal candidates for surgery. Furthermore, patients who continue to experience fatigue and sleepiness on CPAP despite control of OSA may not experience amelioration of these symptoms with HGNS therapy.
Surgery and device management
The surgery, performed under general anesthesia, lasts approximately 3 hours, and may be followed by an overnight hospital stay depending on patient’s comorbidities. The device implantation involves placement of an implantable pulse generator (IPG) in the chest wall and leads to the hypoglossal nerve. The IPG is similar to a pacemaker and functions to stimulate the ipsilateral hypoglossal nerve innervating the tongue during sleep. The most common postoperative complications noted in the STAR trial data include incision site pain and swelling as well as temporary tongue weakness or paresthesia. Postoperative restrictions are minimal and include no heavy lifting for one month after surgery.
One week postsurgery, patients return to the ENT Sleep Surgery Clinic for follow-up, at which time the incisions as well as tongue strength and sensation are evaluated. In a subsequent visit between 4 and 6 weeks postsurgery, patients are evaluated in a joint Sleep Medicine and ENT clinic. They undergo device education and activation of the IPG using a dedicated programmer obtained from the device manufacturer. Device comfort features such as start delay and pause time are also programmed. Furthermore, appropriate tongue movement, lead placement, and voltage range settings are assessed during the visit. The ENT surgery team reevaluates the incision sites and assesses for tongue function and sensation. Patients are instructed to increase the voltage incrementally every week as tolerated with the goal of using the device nightly for the entirety of sleep. If patients tolerate the therapy well during the 2- to 3-month follow-up, a sleep study is scheduled to evaluate treatment effectiveness at the peak tolerable voltage. For those struggling with the therapy, adjustments to electrode configurations should be considered for pulse width, and rate. Occasionally, patients may require awake endoscopy and/or an advanced HGNS titration while asleep to determine the most appropriate settings to optimally control sleep apnea.
Until recently, patients implanted with an early version of the HGNS were limited to magnetic resonance imaging (MRI) scans of the head, neck, and extremities only. However, patients with the latest model IPGs can now undergo full-body MRI scans. It is important to note that the MRI’s Tesla cannot exceed 1.5T, necessitating specific imaging centers. Other constraints include the inability to adjust device settings remotely, which could mean long travel for minor setting adjustments such as altering start delay or pause times. Furthermore, provider education on operating and managing the device can be time consuming and may also be a barrier to implementation in a clinic. Also challenging may be the availability of an ENT surgery, which plays a critical role in the implantation of the devices and follow-up.
Currently, Inspire Medical Systems is the only FDA-approved hypoglossal nerve stimulation device available in the United States, and globally, more than 45,000 patients have been implanted. However, the field of neurostimulation is rapidly growing. Companies like LivaNova have secured Investigational Device Exemption for their HGNS device. The Genio system by Nyxoah is evaluating the use of bilateral hypoglossal nerve stimulation in patients with OSA and complete concentric collapse of the palate. A multidisciplinary Hypoglossal Nerve Stimulation Clinic is an important component of a comprehensive sleep medicine clinic for patient care and medical education. In the appropriate patient, this emerging technology may provide improvement in OSA severity and symptoms.
Dr. Gill is Clinical Associate Professor, Division of Sleep Medicine, Stanford (Calif.) University.
It is estimated that almost one billion people globally are affected by obstructive sleep apnea (OSA) (Benjafield A, et al. Lancet Respir Med. 2019;7[8]:687-98). Despite such high prevalence, the treatment options for OSA are somewhat limited. As per certain estimates, nearly 50% of CPAP users discontinue treatment by the fifth year (Schoch O, et al. Respiration. 2014;87[2]:121-8). Furthermore, alternative options such as mandibular advancement devices, positional therapy, weight loss, and maxillofacial or palate surgery, also have unique challenges and limitations.
First described in 2001, hypoglossal nerve stimulation (HGNS) is a relatively new and emerging technology for the treatment of OSA (Schwartz A, et al. Arch Otolaryngol Head Neck Surg. 2001 Oct;127[10]:1216-23). HGNS therapy was approved by the Food and Drug Administration in 2014 for the treatment of moderate to severe OSA. The therapy involves surgical implantation of the HGNS device, optimization of device settings, and evaluation for treatment response. A physician-led multidisciplinary Hypoglossal Nerve Stimulation Clinic involves collaboration from essential stakeholders, most importantly sleep medicine providers, clinic staff, sleep technologists, and ENT sleep surgeons. Goals of the multidisciplinary program are to ensure timely follow-up, optimization of device settings, and maximizing treatment efficacy. This review describes steps involved in developing a successful multidisciplinary HGNS program within a sleep medicine practice.
Patient selection and evaluation
There is growing interest in HGNS relative to conventional CPAP therapy, with many patients presenting to clinic to inquire about this therapy. However, not all patients are candidates for HGNS therapy. Prioritizing appropriate patient selection and education are key first steps. The initial assessments usually occur with a sleep medicine specialist. It begins with confirmation of the diagnosis of OSA in all patients and a concerted effort to troubleshoot and address any barriers to CPAP use before consideration of surgery. Patients who are unwilling to use or unable to tolerate CPAP therapy undergo further evaluation for HGNS therapy. It is important to ensure that patients are also screened for other sleep disorders, such as insomnia or restless leg syndrome, to rule out its contribution to daytime (or nighttime) symptoms.
Other salient inclusion criteria include an apnea-hypopnea index (AHI) between 15-100 events per hour (previously 65), at least 18 years of age, and a body mass index (BMI) less than 40 kg/m2 (previously 32). Qualifying patients undergo an updated polysomnography if a recent study is not available. If the polysomnography reveals central and mixed apneas comprising less than 25 percent of the total AHI, patients are referred to ENT Sleep Surgery, and drug-induced sleep endoscopy is offered to examine upper airway anatomy. When a complete concentric collapse of the soft palate is seen on drug-induced sleep endoscopy, surgery is contraindicated. Prior palate surgery or maxillomandibular advancement (MMA) are not contraindications to HGNS therapy.
The patients receive comprehensive information on the nature of the surgery, expected recovery course, and device activation timeline. Perhaps most importantly, the patients receive structured education on HGNS therapy and potential outcomes to set realistic expectations. In the STAR trial, patients experienced a reduction in the AHI of approximately 70% (Strollo P, et al. N Engl J Med. 2014;370[2]:139-49). It is important to note that a response to therapy was defined as a reduction in the AHI by at least 50% and a value less than 20 events/hour (Strollo P, et al. Sleep. 2015;38[10]:1593-8). Therefore, patients who are expecting complete resolution of snoring and/or OSA may not be ideal candidates for surgery. Furthermore, patients who continue to experience fatigue and sleepiness on CPAP despite control of OSA may not experience amelioration of these symptoms with HGNS therapy.
Surgery and device management
The surgery, performed under general anesthesia, lasts approximately 3 hours, and may be followed by an overnight hospital stay depending on patient’s comorbidities. The device implantation involves placement of an implantable pulse generator (IPG) in the chest wall and leads to the hypoglossal nerve. The IPG is similar to a pacemaker and functions to stimulate the ipsilateral hypoglossal nerve innervating the tongue during sleep. The most common postoperative complications noted in the STAR trial data include incision site pain and swelling as well as temporary tongue weakness or paresthesia. Postoperative restrictions are minimal and include no heavy lifting for one month after surgery.
One week postsurgery, patients return to the ENT Sleep Surgery Clinic for follow-up, at which time the incisions as well as tongue strength and sensation are evaluated. In a subsequent visit between 4 and 6 weeks postsurgery, patients are evaluated in a joint Sleep Medicine and ENT clinic. They undergo device education and activation of the IPG using a dedicated programmer obtained from the device manufacturer. Device comfort features such as start delay and pause time are also programmed. Furthermore, appropriate tongue movement, lead placement, and voltage range settings are assessed during the visit. The ENT surgery team reevaluates the incision sites and assesses for tongue function and sensation. Patients are instructed to increase the voltage incrementally every week as tolerated with the goal of using the device nightly for the entirety of sleep. If patients tolerate the therapy well during the 2- to 3-month follow-up, a sleep study is scheduled to evaluate treatment effectiveness at the peak tolerable voltage. For those struggling with the therapy, adjustments to electrode configurations should be considered for pulse width, and rate. Occasionally, patients may require awake endoscopy and/or an advanced HGNS titration while asleep to determine the most appropriate settings to optimally control sleep apnea.
Until recently, patients implanted with an early version of the HGNS were limited to magnetic resonance imaging (MRI) scans of the head, neck, and extremities only. However, patients with the latest model IPGs can now undergo full-body MRI scans. It is important to note that the MRI’s Tesla cannot exceed 1.5T, necessitating specific imaging centers. Other constraints include the inability to adjust device settings remotely, which could mean long travel for minor setting adjustments such as altering start delay or pause times. Furthermore, provider education on operating and managing the device can be time consuming and may also be a barrier to implementation in a clinic. Also challenging may be the availability of an ENT surgery, which plays a critical role in the implantation of the devices and follow-up.
Currently, Inspire Medical Systems is the only FDA-approved hypoglossal nerve stimulation device available in the United States, and globally, more than 45,000 patients have been implanted. However, the field of neurostimulation is rapidly growing. Companies like LivaNova have secured Investigational Device Exemption for their HGNS device. The Genio system by Nyxoah is evaluating the use of bilateral hypoglossal nerve stimulation in patients with OSA and complete concentric collapse of the palate. A multidisciplinary Hypoglossal Nerve Stimulation Clinic is an important component of a comprehensive sleep medicine clinic for patient care and medical education. In the appropriate patient, this emerging technology may provide improvement in OSA severity and symptoms.
Dr. Gill is Clinical Associate Professor, Division of Sleep Medicine, Stanford (Calif.) University.
Self-reported symptoms of postpartum depression in the United States, 2018
Positive topline results for antihypertensive zilebesiran
Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.
KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.
Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.
The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.
Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.
The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.
There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.
Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.
“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.
The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.
The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.
A version of this article first appeared on Medscape.com.
Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.
KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.
Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.
The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.
Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.
The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.
There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.
Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.
“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.
The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.
The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.
A version of this article first appeared on Medscape.com.
Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.
KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.
Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.
The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.
Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.
The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.
There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.
Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.
“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.
The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.
The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.
A version of this article first appeared on Medscape.com.
Pandemic tied to significant drop in residents’ PTSD rates
TOPLINE
First-year medical residents training during COVID-19 were significantly less likely to have posttraumatic stress disorder and workplace trauma, compared with their counterparts who trained before the pandemic, and reported fewer work hours, higher workload satisfaction, and fewer medical errors, new research shows.
METHODOLOGY
- Studies have reported a high prevalence of PTSD symptoms among residents during the pandemic, but it’s unclear if this prevalence differs from prepandemic levels.
- Using the Intern Health Study, a longitudinal cohort study of 1st-year residents, researchers investigated differences in PTSD symptoms among those training before the pandemic (2018-2019) and during its first wave (March to June, 2020).
- The study included 1,957 first-year residents (48.2% female; mean age, 27.6 years) who completed a baseline survey 2 months before their residency start, and then quarterly surveys during their intern year, with the fourth quarterly survey including a screen for PTSD.
- Researchers assessed differences in nonresidency factors and residency-related factors before and during the pandemic and examined exposure to workplace trauma.
TAKEAWAY
- (7.1% vs. 10.7%; odds ratio, 0.64; 95% confidence interval, 0.46-0.88; P = .01).
- They were also less likely to have workplace trauma exposure (50.9% vs. 56.6%; OR, 0.80; 95% CI, 0.66-0.95; P = .01).
- Residents training during the pandemic compared to prepandemic reported significantly lower weekly duty hours (score mean difference –3.1 hours; 95% CI, –4.1 to −2.0 hours), lower mean reports of medical errors (MD, −0.04; 95% CI, –0.06 to –0.01), and higher workload satisfaction (MD, 0.2; 95% CI, 0.2-0.3).
- However, after accounting for these residency-related factors, training during the pandemic was no longer associated with lower odds of presenting PTSD symptoms.
IN PRACTICE
While the findings show residents training during the first pandemic wave were less likely to have PTSD, future studies should further follow these residents’ PTSD symptoms and investigate whether interventions targeting residency-related factors could reduce their PTSD risk moving forward, the investigators note.
SOURCE
The study was carried out by Michelle K. Ptak, BA, department of psychology, University of Michigan, Ann Arbor, and colleagues. It was published online Aug. 22 in JAMA Network Open.
LIMITATIONS
The study used self-reports and included only the first pandemic wave, 1st-year residents, and prepandemic data for a single academic year. Survey participation decreased during the pandemic, and it’s possible there were unmeasured factors associated with PTSD risk.
DISCLOSURES
The study was supported by the National Institute of Mental Health and the National Institutes of Health. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE
First-year medical residents training during COVID-19 were significantly less likely to have posttraumatic stress disorder and workplace trauma, compared with their counterparts who trained before the pandemic, and reported fewer work hours, higher workload satisfaction, and fewer medical errors, new research shows.
METHODOLOGY
- Studies have reported a high prevalence of PTSD symptoms among residents during the pandemic, but it’s unclear if this prevalence differs from prepandemic levels.
- Using the Intern Health Study, a longitudinal cohort study of 1st-year residents, researchers investigated differences in PTSD symptoms among those training before the pandemic (2018-2019) and during its first wave (March to June, 2020).
- The study included 1,957 first-year residents (48.2% female; mean age, 27.6 years) who completed a baseline survey 2 months before their residency start, and then quarterly surveys during their intern year, with the fourth quarterly survey including a screen for PTSD.
- Researchers assessed differences in nonresidency factors and residency-related factors before and during the pandemic and examined exposure to workplace trauma.
TAKEAWAY
- (7.1% vs. 10.7%; odds ratio, 0.64; 95% confidence interval, 0.46-0.88; P = .01).
- They were also less likely to have workplace trauma exposure (50.9% vs. 56.6%; OR, 0.80; 95% CI, 0.66-0.95; P = .01).
- Residents training during the pandemic compared to prepandemic reported significantly lower weekly duty hours (score mean difference –3.1 hours; 95% CI, –4.1 to −2.0 hours), lower mean reports of medical errors (MD, −0.04; 95% CI, –0.06 to –0.01), and higher workload satisfaction (MD, 0.2; 95% CI, 0.2-0.3).
- However, after accounting for these residency-related factors, training during the pandemic was no longer associated with lower odds of presenting PTSD symptoms.
IN PRACTICE
While the findings show residents training during the first pandemic wave were less likely to have PTSD, future studies should further follow these residents’ PTSD symptoms and investigate whether interventions targeting residency-related factors could reduce their PTSD risk moving forward, the investigators note.
SOURCE
The study was carried out by Michelle K. Ptak, BA, department of psychology, University of Michigan, Ann Arbor, and colleagues. It was published online Aug. 22 in JAMA Network Open.
LIMITATIONS
The study used self-reports and included only the first pandemic wave, 1st-year residents, and prepandemic data for a single academic year. Survey participation decreased during the pandemic, and it’s possible there were unmeasured factors associated with PTSD risk.
DISCLOSURES
The study was supported by the National Institute of Mental Health and the National Institutes of Health. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE
First-year medical residents training during COVID-19 were significantly less likely to have posttraumatic stress disorder and workplace trauma, compared with their counterparts who trained before the pandemic, and reported fewer work hours, higher workload satisfaction, and fewer medical errors, new research shows.
METHODOLOGY
- Studies have reported a high prevalence of PTSD symptoms among residents during the pandemic, but it’s unclear if this prevalence differs from prepandemic levels.
- Using the Intern Health Study, a longitudinal cohort study of 1st-year residents, researchers investigated differences in PTSD symptoms among those training before the pandemic (2018-2019) and during its first wave (March to June, 2020).
- The study included 1,957 first-year residents (48.2% female; mean age, 27.6 years) who completed a baseline survey 2 months before their residency start, and then quarterly surveys during their intern year, with the fourth quarterly survey including a screen for PTSD.
- Researchers assessed differences in nonresidency factors and residency-related factors before and during the pandemic and examined exposure to workplace trauma.
TAKEAWAY
- (7.1% vs. 10.7%; odds ratio, 0.64; 95% confidence interval, 0.46-0.88; P = .01).
- They were also less likely to have workplace trauma exposure (50.9% vs. 56.6%; OR, 0.80; 95% CI, 0.66-0.95; P = .01).
- Residents training during the pandemic compared to prepandemic reported significantly lower weekly duty hours (score mean difference –3.1 hours; 95% CI, –4.1 to −2.0 hours), lower mean reports of medical errors (MD, −0.04; 95% CI, –0.06 to –0.01), and higher workload satisfaction (MD, 0.2; 95% CI, 0.2-0.3).
- However, after accounting for these residency-related factors, training during the pandemic was no longer associated with lower odds of presenting PTSD symptoms.
IN PRACTICE
While the findings show residents training during the first pandemic wave were less likely to have PTSD, future studies should further follow these residents’ PTSD symptoms and investigate whether interventions targeting residency-related factors could reduce their PTSD risk moving forward, the investigators note.
SOURCE
The study was carried out by Michelle K. Ptak, BA, department of psychology, University of Michigan, Ann Arbor, and colleagues. It was published online Aug. 22 in JAMA Network Open.
LIMITATIONS
The study used self-reports and included only the first pandemic wave, 1st-year residents, and prepandemic data for a single academic year. Survey participation decreased during the pandemic, and it’s possible there were unmeasured factors associated with PTSD risk.
DISCLOSURES
The study was supported by the National Institute of Mental Health and the National Institutes of Health. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
How ob.gyn. programs provide abortion training post Dobbs
to fulfill required clinical rotations in the procedure.
The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.
Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.
These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.
A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.
While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.
A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.
The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.
“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”
This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.
Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.
The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
Connecting programs
Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.
Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.
Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.
“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”
OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.
The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.
To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.
The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
Training costs
Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.
OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.
Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.
Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.
The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.
UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.
OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”
A version of this article first appeared on Medscape.com.
to fulfill required clinical rotations in the procedure.
The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.
Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.
These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.
A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.
While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.
A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.
The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.
“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”
This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.
Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.
The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
Connecting programs
Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.
Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.
Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.
“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”
OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.
The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.
To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.
The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
Training costs
Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.
OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.
Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.
Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.
The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.
UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.
OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”
A version of this article first appeared on Medscape.com.
to fulfill required clinical rotations in the procedure.
The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.
Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.
These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.
A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.
While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.
A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.
The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.
“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”
This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.
Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.
The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
Connecting programs
Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.
Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.
Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.
“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”
OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.
The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.
To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.
The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
Training costs
Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.
OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.
Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.
Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.
The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.
UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.
OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”
A version of this article first appeared on Medscape.com.