The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

sworcester@mdedge.com

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

sworcester@mdedge.com

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

sworcester@mdedge.com

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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

Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.

Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.

Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
 

At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?

I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.

But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.

Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
 

What is your current role at Beth Israel Deaconess Medical Center?

At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.

What are your favorite areas of clinical practice and research?

Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.

The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.

I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
 

What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?

The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.

It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
 

How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?

What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.

After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
 

How will hospital medicine as a field change in the next decade or 2?

The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.

Are there any particular mentors who have been influential in your journey as a hospitalist?

Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.

Do you have any advice for students and residents interested in hospital medicine?

When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.

I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
 

Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.

Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.

Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
 

At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?

I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.

But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.

Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
 

What is your current role at Beth Israel Deaconess Medical Center?

At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.

What are your favorite areas of clinical practice and research?

Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.

The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.

I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
 

What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?

The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.

It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
 

How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?

What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.

After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
 

How will hospital medicine as a field change in the next decade or 2?

The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.

Are there any particular mentors who have been influential in your journey as a hospitalist?

Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.

Do you have any advice for students and residents interested in hospital medicine?

When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.

I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
 

Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.

Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.

Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
 

At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?

I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.

But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.

Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
 

What is your current role at Beth Israel Deaconess Medical Center?

At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.

What are your favorite areas of clinical practice and research?

Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.

The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.

I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
 

What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?

The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.

It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
 

How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?

What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.

After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
 

How will hospital medicine as a field change in the next decade or 2?

The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.

Are there any particular mentors who have been influential in your journey as a hospitalist?

Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.

Do you have any advice for students and residents interested in hospital medicine?

When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.

I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
 

The Diagnosis: Cutaneous Metaplastic Synovial Cyst 

Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).  

Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al¹ in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.² Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,³ distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,^3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.⁵ Relative tissue fragility secondary to rheumatoid arthritis¹⁰ and Ehlers-Danlos syndrome^9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.^13-15 

As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.¹⁶ Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,¹⁷ which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.¹⁸ Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.¹⁹ Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist. 

Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.⁶ Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion. 

The Diagnosis: Cutaneous Metaplastic Synovial Cyst 

Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).  

Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al¹ in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.² Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,³ distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,^3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.⁵ Relative tissue fragility secondary to rheumatoid arthritis¹⁰ and Ehlers-Danlos syndrome^9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.^13-15 

As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.¹⁶ Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,¹⁷ which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.¹⁸ Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.¹⁹ Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist. 

Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.⁶ Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion. 

The Diagnosis: Cutaneous Metaplastic Synovial Cyst 

Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).  

Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al¹ in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.² Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,³ distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,^3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.⁵ Relative tissue fragility secondary to rheumatoid arthritis¹⁰ and Ehlers-Danlos syndrome^9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.^13-15 

As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.¹⁶ Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,¹⁷ which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.¹⁸ Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.¹⁹ Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist. 

Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.⁶ Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion. 

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

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

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

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

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

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