As we approach the end of this year, one of the most surreal times in human history, we will look back on the many things we taught ourselves, the many things we took for granted, the many things we were grateful for, the many things we missed, and the many things we plan to do once we can do things again. Among the many things 2020 taught us to appreciate was the very real manifestation of the old adage, “prevention is the best medicine.” To prevent transmission of SARS-CoV-2, we wore masks, we sanitized everything, we avoided crowds, we traded in-person meetings for virtual meetings, we learned how to homeschool our children, and we delayed seeing relatives and friends.

Ob.gyns. in small and large practices around the world had the tremendous challenge of balancing necessary in-person prenatal care services with keeping their patients and babies safe. Labor and delivery units had even greater demands to keep women and neonates free of SARS-CoV-2 infection. Practices quickly put into place new treatment protocols and new management strategies to maintain the health of their staff while ensuring a high quality of care.

While we have focused much of our attention on greater precautions during pregnancy and childbirth, an important component of care is the immediate postpartum period – colloquially referred to as the “fourth trimester” – which remains critical to maintaining physical and mental health and well-being.

Despite concerns regarding COVID-19 safety, we should continue monitoring our patients during these crucial first weeks after childbirth. This year of social isolation, financial strain, and incredible uncertainty has created additional stress in many women’s lives. The usual support that some women would receive from family members, friends, and other mothers in the early days post partum may not be available. The pandemic also has further highlighted inequities in access to health care for vulnerable groups. In addition, restrictions have increased the incidence of intimate partner violence as many women and children have needed to shelter with their abusers. Perhaps now more than any time previously, ob.gyns. must be attuned to their patients’ needs and be ready to provide compassionate and sensitive care.

In this final month of the year, we have invited George A. Macones, MD, professor and chair of the department of women’s health at the University of Texas, Austin, to address the importance of care in the final “trimester” of pregnancy – the first 3 months post partum.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

*This version has been updated to correct an erroneous byline, photo, and bio.

As we approach the end of this year, one of the most surreal times in human history, we will look back on the many things we taught ourselves, the many things we took for granted, the many things we were grateful for, the many things we missed, and the many things we plan to do once we can do things again. Among the many things 2020 taught us to appreciate was the very real manifestation of the old adage, “prevention is the best medicine.” To prevent transmission of SARS-CoV-2, we wore masks, we sanitized everything, we avoided crowds, we traded in-person meetings for virtual meetings, we learned how to homeschool our children, and we delayed seeing relatives and friends.

Ob.gyns. in small and large practices around the world had the tremendous challenge of balancing necessary in-person prenatal care services with keeping their patients and babies safe. Labor and delivery units had even greater demands to keep women and neonates free of SARS-CoV-2 infection. Practices quickly put into place new treatment protocols and new management strategies to maintain the health of their staff while ensuring a high quality of care.

While we have focused much of our attention on greater precautions during pregnancy and childbirth, an important component of care is the immediate postpartum period – colloquially referred to as the “fourth trimester” – which remains critical to maintaining physical and mental health and well-being.

Despite concerns regarding COVID-19 safety, we should continue monitoring our patients during these crucial first weeks after childbirth. This year of social isolation, financial strain, and incredible uncertainty has created additional stress in many women’s lives. The usual support that some women would receive from family members, friends, and other mothers in the early days post partum may not be available. The pandemic also has further highlighted inequities in access to health care for vulnerable groups. In addition, restrictions have increased the incidence of intimate partner violence as many women and children have needed to shelter with their abusers. Perhaps now more than any time previously, ob.gyns. must be attuned to their patients’ needs and be ready to provide compassionate and sensitive care.

In this final month of the year, we have invited George A. Macones, MD, professor and chair of the department of women’s health at the University of Texas, Austin, to address the importance of care in the final “trimester” of pregnancy – the first 3 months post partum.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

*This version has been updated to correct an erroneous byline, photo, and bio.

As we approach the end of this year, one of the most surreal times in human history, we will look back on the many things we taught ourselves, the many things we took for granted, the many things we were grateful for, the many things we missed, and the many things we plan to do once we can do things again. Among the many things 2020 taught us to appreciate was the very real manifestation of the old adage, “prevention is the best medicine.” To prevent transmission of SARS-CoV-2, we wore masks, we sanitized everything, we avoided crowds, we traded in-person meetings for virtual meetings, we learned how to homeschool our children, and we delayed seeing relatives and friends.

Ob.gyns. in small and large practices around the world had the tremendous challenge of balancing necessary in-person prenatal care services with keeping their patients and babies safe. Labor and delivery units had even greater demands to keep women and neonates free of SARS-CoV-2 infection. Practices quickly put into place new treatment protocols and new management strategies to maintain the health of their staff while ensuring a high quality of care.

While we have focused much of our attention on greater precautions during pregnancy and childbirth, an important component of care is the immediate postpartum period – colloquially referred to as the “fourth trimester” – which remains critical to maintaining physical and mental health and well-being.

Despite concerns regarding COVID-19 safety, we should continue monitoring our patients during these crucial first weeks after childbirth. This year of social isolation, financial strain, and incredible uncertainty has created additional stress in many women’s lives. The usual support that some women would receive from family members, friends, and other mothers in the early days post partum may not be available. The pandemic also has further highlighted inequities in access to health care for vulnerable groups. In addition, restrictions have increased the incidence of intimate partner violence as many women and children have needed to shelter with their abusers. Perhaps now more than any time previously, ob.gyns. must be attuned to their patients’ needs and be ready to provide compassionate and sensitive care.

In this final month of the year, we have invited George A. Macones, MD, professor and chair of the department of women’s health at the University of Texas, Austin, to address the importance of care in the final “trimester” of pregnancy – the first 3 months post partum.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

*This version has been updated to correct an erroneous byline, photo, and bio.

CASE A passive wish to die

Ms. M, age 76, has a history of major depressive disorder, unspecified anxiety disorder, and severe chronic obstructive pulmonary disease (COPD), for which she requires supplemental oxygen. She is admitted to a psychiatric hospital after several months of increased dysphoria, rumination, anhedonia, and a passive wish to die. She also has a decreased appetite and has lost 10 lb, experiences frequent daily episodes of shortness of breath and associated racing thoughts, and has a rapid heart rate.

HISTORY Past medication trials

In addition to COPD, Ms. M’s medical history includes hypertension. Past psychotropic medication trials used to treat her depression and anxiety have included aripiprazole, 5 mg/d; duloxetine, 60 mg/d; fluoxetine, 40 mg/d; mirtazapine, 30 mg nightly; buspirone, 10 mg twice daily; and clonazepam, 0.5 mg twice daily. She has no history of psychotherapy, and because of her uncontrolled anxiety and depression, she has never completed a pulmonary rehabilitation program.

Her current medications include salmeterol, 50 mcg inhaled twice daily, for COPD; amlodipine, 10 mg/d, for hypertension; buspirone, 10 mg twice daily, for anxiety; and duloxetine, 60 mg/d, for depression.

EXAMINATION No evidence of dementia

On examination, Ms. M is alert and oriented to person, place, date, and situation. Overall, she has mild difficulty with attention and short-term recall, which appears to be due to poor effort; intact long-term memory; and is able to abstract appropriately. There is no evidence of dementia.

A mental status exam reveals a frail, elderly woman with fair-to-poor hygiene, cooperative behavior, slowed motor activity, slowed speech with low volume, low mood, and depressed affect with constricted range. Her thought process is linear, her thought content includes passive death wishes, and she does not have hallucinations.

Bitemporal electroconvulsive therapy (ECT), 1.0 ms pulse width at 1.5 times Ms. M’s seizure threshold 3 times weekly, is initiated to treat her depression, with seizure duration averaging 45 seconds for each session. She receives a total of 8 treatments over the course of admission. Buspirone, 10 mg twice daily, is stopped shortly after admission, but she continues to receive duloxetine, 60 mg/d. Ms. M continues to have shortness of breath, palpitations, fearful ruminations about the future, and difficulty falling asleep.

[polldaddy:10673878]

The authors’ observations

The treatment team explores other options, such as benzodiazepines, psychotherapy modalities, and mindfulness exercises, to treat Ms. M’s anxiety and comorbid COPD. Lorazepam, 0.5 mg twice daily, was chosen to treat her acute anxiety. Due to Ms. M’s need for supplemental oxygen, the treatment team attempted to mitigate the risk of using a benzodiazepine by limiting its use to the minimum effective dose. The teams also looked for alternative therapies.

Continue to: Evalution of anxiety...

Evaluation of anxiety and depression in a patient with COPD is complicated by a high degree of symptom overlap. Patients with COPD may experience anxiety symptoms such as shortness of breath, rapid heart rate, numbness/tingling, and racing thoughts, and/or depressive symptoms such as decreased energy, impaired sleep, and impaired concentration. It can therefore be difficult to discern if a symptom is attributable to the physical diagnosis, the psychiatric diagnosis, or a combination of both. Catastrophic thinking about mild physical symptoms is common in patients with COPD. This can lead to hyperventilation and hypocapnia (manifested by lightheadedness, dizziness, paresthesia, and altered consciousness), with a reciprocally escalating cascade of anxiety and somatic symptoms.¹

First-line therapy for anxiety disorders with comorbid COPD is CBT and other nonpharmacologic interventions.^2,3However, access to CBT-trained psychotherapists is limited due to the cost and a shortage of qualified professionals.⁴ One randomized clinical trial evaluated improving accessibility to this therapy by training respiratory therapists to perform CBT sessions for COPD patients who were anxious and depressed.⁴ This method was as successful as using CBT-trained psychotherapists, and also reduced emergency room visits and hospitalizations in this population.⁴ Respiratory therapists often intuitively use CBT concepts in coaching patients and generally have the knowledge and background to be able to help patients identify symptoms caused by anxiety vs when to seek additional medical support. Furthermore, these interventions have been shown to increase quality-adjusted life years,⁴ improve physical performance, and reduce symptoms of anxiety and depression as reported on the Beck Anxiety Inventory and Beck Depression Inventory.⁵ In addition to relaxation/imagery training, cognitive restructuring, breathing retraining, and maintaining daily symptom logs, CBT for COPD may include interoceptive exposure therapy. This technique involves deliberately inducing hyperventilation, followed by desensitization exercises to uncouple any uncomfortable physical sensations with the conditioned fear response.¹

Although there is little evidence that traditional pharmacologic treatments (eg, antidepressants, benzodiazepines) have a statistically significant effect on anxiety and depression in COPD, studies have found that they have some clinical benefit.³ Risks, however, limit the utility of certain agents. Sedative-hypnotics potentially decrease respiratory drive and, particularly in older patients, antidepressants’ sedating effects can increase the risk of falls³ leading to increased morbidity, hospitalization, and mortality.

TREATMENT Mindfulness techniques and meditation

Ms. M’s symptoms show no improvement with the addition of lorazepam, 0.5 mg twice daily. A clinician teaches Ms. M mindfulness techniques, and she begins a trial of daily, individual, guided meditation using a meditation app. Respiratory therapists also instruct her on controlled breathing techniques such as pursed-lips breathing, diaphragmatic breathing, and deep breathing. They also encourage Ms. M to participate in the daily exercise group while on the unit.

[polldaddy:10673881]

The authors’ observations

Research indicates that low doses of opioids are safe and effective for refractory breathlessness in patients with severe COPD(those with an arterial partial pressure of oxygen ≤55 mm Hg or arterial oxygen saturation ≤88%).^6,7 Patients at this advanced stage of illness have likely been started on oxygen therapy to improve survival but may need additional palliative measures to alleviate the discomfort associated with the severe breathlessness experienced at this stage.⁸ In such situations, low-dose opioids, such as immediate-release morphine, 1 mg/d given as 0.5 mg twice daily, can be started.⁸ The dose can be increased by 0.5 mg until a therapeutic dose is achieved.⁸ Alternately, 24-hour extended-release morphine, 20 mg/d, or an equivalent dose of oxycodone or hydromorphone, can be prescribed.⁸ The proposed therapeutic mechanisms of low-dose opioids for these patients include decreasing one’s sense of effort, altering central perception, altering activity of peripheral opioid receptors located in the lung, and decreasing anxiety.⁸

Continue to: The current opioid crisis...

The current opioid crisis prompts additional caution in prescribing, especially when considering using short-acting, immediate-release opioids such as morphine, which have a greater potential for abuse and dependence. The Table lists safeguards that should be implemented when prescribing opioids.

Many patients with COPD in the end-of-life phase and in severe pain or discomfort due to the advanced stages of their illness receive opioids as part of palliative care. Patients with COPD whose medical care is predominantly palliative may benefit greatly from being prescribed opioids. Most patients with COPD who find relief from low-dose opioids usually have 6 to 12 months to live, and low-dose opioids may help them obtain the best possible quality of life.

Choosing opioids as a treatment involves the risk of physiologic dependence and opioid use disorder. For Ms. M, the potential benefits were thought to outweigh such risks.

OUTCOME Breathlessness improves, anxiety decreases

Ms. M’s lorazepam is discontinued, and immediate-release morphine is prescribed at a low dose of 1 mg/d on an as-needed basis for anxiety with good effect. Ms. M’s breathlessness improves, leading to an overall decrease in anxiety. She does not experience sedation, confusion, or adverse respiratory effects.

Ms. M’s anxiety and depression improve over the course of the hospitalization with this regimen. On hospital Day 25, she is discharged with a plan to continue duloxetine, 60 mg/d, ECT twice weekly, and low-dose morphine, 1 mg/d, as needed for anxiety. She is referred for pulmonary rehabilitation and CBT to maintain remission.

[polldaddy:10673882]

Continue to: The authors' observations

Ms. M’s case highlights several challenges associated with treating psychiatric illness in a patient with a chronic medical illness. The relationship between COPD, anxiety, and depression is complex, and is associated with reduced quality of life, increasing severity of pulmonary disease, increased dyspnea, a sense of loss and inability to cope, and decreased self-efficacy and adherence to treatment.^9-11Adding supplemental oxygen has been shown to improve longevity, and may help boost mood and lessen anxiety in some patients, whereas others find its restrictions burdensome and demoralizing.⁸ Pulmonary rehabilitation programs are a key component of both secondary prevention and treatment in improving overall health outcomes in patients with COPD,¹² and can be started at any stage of the illness. However, patients with comorbid anxiety and depression are often the least likely to engage in these programs.^4,13 One program that offered management of depression and COPD care with a focus on misconceptions about treatment and obstacles to treatment engagement reduced depressive symptoms and dyspnea-related disability, which led to greater remission of depression.^14,15 Exercise training in such programs also helps manage avoidance of physical activity due to fear of dyspnea by allowing patients to experience feared symptoms in the presence of medical professionals, similar to the CBT interoceptive exposure technique described earlier.¹ Several traditional treatment modalities used to target Ms. M’s anxiety disorder were unsuccessful. Low-dose, as-needed opioids are a safe and useful pharmacologic option worth considering for patients with refractory anxiety and depression and comorbid COPD.

Bottom Line

When traditional antidepressant and anxiolytic therapies have not sufficiently helped, consider low-dose, once-daily opioids to address refractory breathlessness in a patient with COPD with comorbid anxiety and depression. This treatment can lead patients to participate in rehabilitation therapies and improve their quality of life.

Related Resources

• Alexopoulos G, Kiosses D, Sirey J, et al. Untangling therapeutic ingredients of a personalized intervention for patients with depression and severe COPD. Am J Geriatr Psychiatry. 2014;22(11):1316-1324.
• Jackson D, Banerjee S, Sirey J, et al. Two interventions for patients with major depression and severe chronic obstructive pulmonary disease: impact on quality of life. Am J Geriatr Psychiatry. 2018;27(5):502-511.

Drug Brand Names

Amlodipine • Norvasc
Aripiprazole • Abilify
Buspirone • Buspar
Clonazepam • Klonopin
Duloxetine • Cymbalta
Fluoxetine • Prozac
Hydromorphone • Dilaudid
Levodopa • Sinemet
Lorazepam • Ativan
Mirtazapine • Remeron
Morphine • MS Contin
Naloxone • Narcan
Oxycodone • Oxycontin
Salmeterol • Serevent Diskus

CASE A passive wish to die

Ms. M, age 76, has a history of major depressive disorder, unspecified anxiety disorder, and severe chronic obstructive pulmonary disease (COPD), for which she requires supplemental oxygen. She is admitted to a psychiatric hospital after several months of increased dysphoria, rumination, anhedonia, and a passive wish to die. She also has a decreased appetite and has lost 10 lb, experiences frequent daily episodes of shortness of breath and associated racing thoughts, and has a rapid heart rate.

HISTORY Past medication trials

In addition to COPD, Ms. M’s medical history includes hypertension. Past psychotropic medication trials used to treat her depression and anxiety have included aripiprazole, 5 mg/d; duloxetine, 60 mg/d; fluoxetine, 40 mg/d; mirtazapine, 30 mg nightly; buspirone, 10 mg twice daily; and clonazepam, 0.5 mg twice daily. She has no history of psychotherapy, and because of her uncontrolled anxiety and depression, she has never completed a pulmonary rehabilitation program.

Her current medications include salmeterol, 50 mcg inhaled twice daily, for COPD; amlodipine, 10 mg/d, for hypertension; buspirone, 10 mg twice daily, for anxiety; and duloxetine, 60 mg/d, for depression.

EXAMINATION No evidence of dementia

On examination, Ms. M is alert and oriented to person, place, date, and situation. Overall, she has mild difficulty with attention and short-term recall, which appears to be due to poor effort; intact long-term memory; and is able to abstract appropriately. There is no evidence of dementia.

A mental status exam reveals a frail, elderly woman with fair-to-poor hygiene, cooperative behavior, slowed motor activity, slowed speech with low volume, low mood, and depressed affect with constricted range. Her thought process is linear, her thought content includes passive death wishes, and she does not have hallucinations.

Bitemporal electroconvulsive therapy (ECT), 1.0 ms pulse width at 1.5 times Ms. M’s seizure threshold 3 times weekly, is initiated to treat her depression, with seizure duration averaging 45 seconds for each session. She receives a total of 8 treatments over the course of admission. Buspirone, 10 mg twice daily, is stopped shortly after admission, but she continues to receive duloxetine, 60 mg/d. Ms. M continues to have shortness of breath, palpitations, fearful ruminations about the future, and difficulty falling asleep.

[polldaddy:10673878]

The authors’ observations

The treatment team explores other options, such as benzodiazepines, psychotherapy modalities, and mindfulness exercises, to treat Ms. M’s anxiety and comorbid COPD. Lorazepam, 0.5 mg twice daily, was chosen to treat her acute anxiety. Due to Ms. M’s need for supplemental oxygen, the treatment team attempted to mitigate the risk of using a benzodiazepine by limiting its use to the minimum effective dose. The teams also looked for alternative therapies.

Continue to: Evalution of anxiety...

Evaluation of anxiety and depression in a patient with COPD is complicated by a high degree of symptom overlap. Patients with COPD may experience anxiety symptoms such as shortness of breath, rapid heart rate, numbness/tingling, and racing thoughts, and/or depressive symptoms such as decreased energy, impaired sleep, and impaired concentration. It can therefore be difficult to discern if a symptom is attributable to the physical diagnosis, the psychiatric diagnosis, or a combination of both. Catastrophic thinking about mild physical symptoms is common in patients with COPD. This can lead to hyperventilation and hypocapnia (manifested by lightheadedness, dizziness, paresthesia, and altered consciousness), with a reciprocally escalating cascade of anxiety and somatic symptoms.¹

First-line therapy for anxiety disorders with comorbid COPD is CBT and other nonpharmacologic interventions.^2,3However, access to CBT-trained psychotherapists is limited due to the cost and a shortage of qualified professionals.⁴ One randomized clinical trial evaluated improving accessibility to this therapy by training respiratory therapists to perform CBT sessions for COPD patients who were anxious and depressed.⁴ This method was as successful as using CBT-trained psychotherapists, and also reduced emergency room visits and hospitalizations in this population.⁴ Respiratory therapists often intuitively use CBT concepts in coaching patients and generally have the knowledge and background to be able to help patients identify symptoms caused by anxiety vs when to seek additional medical support. Furthermore, these interventions have been shown to increase quality-adjusted life years,⁴ improve physical performance, and reduce symptoms of anxiety and depression as reported on the Beck Anxiety Inventory and Beck Depression Inventory.⁵ In addition to relaxation/imagery training, cognitive restructuring, breathing retraining, and maintaining daily symptom logs, CBT for COPD may include interoceptive exposure therapy. This technique involves deliberately inducing hyperventilation, followed by desensitization exercises to uncouple any uncomfortable physical sensations with the conditioned fear response.¹

Although there is little evidence that traditional pharmacologic treatments (eg, antidepressants, benzodiazepines) have a statistically significant effect on anxiety and depression in COPD, studies have found that they have some clinical benefit.³ Risks, however, limit the utility of certain agents. Sedative-hypnotics potentially decrease respiratory drive and, particularly in older patients, antidepressants’ sedating effects can increase the risk of falls³ leading to increased morbidity, hospitalization, and mortality.

TREATMENT Mindfulness techniques and meditation

Ms. M’s symptoms show no improvement with the addition of lorazepam, 0.5 mg twice daily. A clinician teaches Ms. M mindfulness techniques, and she begins a trial of daily, individual, guided meditation using a meditation app. Respiratory therapists also instruct her on controlled breathing techniques such as pursed-lips breathing, diaphragmatic breathing, and deep breathing. They also encourage Ms. M to participate in the daily exercise group while on the unit.

[polldaddy:10673881]

The authors’ observations

Research indicates that low doses of opioids are safe and effective for refractory breathlessness in patients with severe COPD(those with an arterial partial pressure of oxygen ≤55 mm Hg or arterial oxygen saturation ≤88%).^6,7 Patients at this advanced stage of illness have likely been started on oxygen therapy to improve survival but may need additional palliative measures to alleviate the discomfort associated with the severe breathlessness experienced at this stage.⁸ In such situations, low-dose opioids, such as immediate-release morphine, 1 mg/d given as 0.5 mg twice daily, can be started.⁸ The dose can be increased by 0.5 mg until a therapeutic dose is achieved.⁸ Alternately, 24-hour extended-release morphine, 20 mg/d, or an equivalent dose of oxycodone or hydromorphone, can be prescribed.⁸ The proposed therapeutic mechanisms of low-dose opioids for these patients include decreasing one’s sense of effort, altering central perception, altering activity of peripheral opioid receptors located in the lung, and decreasing anxiety.⁸

Continue to: The current opioid crisis...

The current opioid crisis prompts additional caution in prescribing, especially when considering using short-acting, immediate-release opioids such as morphine, which have a greater potential for abuse and dependence. The Table lists safeguards that should be implemented when prescribing opioids.

Many patients with COPD in the end-of-life phase and in severe pain or discomfort due to the advanced stages of their illness receive opioids as part of palliative care. Patients with COPD whose medical care is predominantly palliative may benefit greatly from being prescribed opioids. Most patients with COPD who find relief from low-dose opioids usually have 6 to 12 months to live, and low-dose opioids may help them obtain the best possible quality of life.

Choosing opioids as a treatment involves the risk of physiologic dependence and opioid use disorder. For Ms. M, the potential benefits were thought to outweigh such risks.

OUTCOME Breathlessness improves, anxiety decreases

Ms. M’s lorazepam is discontinued, and immediate-release morphine is prescribed at a low dose of 1 mg/d on an as-needed basis for anxiety with good effect. Ms. M’s breathlessness improves, leading to an overall decrease in anxiety. She does not experience sedation, confusion, or adverse respiratory effects.

Ms. M’s anxiety and depression improve over the course of the hospitalization with this regimen. On hospital Day 25, she is discharged with a plan to continue duloxetine, 60 mg/d, ECT twice weekly, and low-dose morphine, 1 mg/d, as needed for anxiety. She is referred for pulmonary rehabilitation and CBT to maintain remission.

[polldaddy:10673882]

Continue to: The authors' observations

Ms. M’s case highlights several challenges associated with treating psychiatric illness in a patient with a chronic medical illness. The relationship between COPD, anxiety, and depression is complex, and is associated with reduced quality of life, increasing severity of pulmonary disease, increased dyspnea, a sense of loss and inability to cope, and decreased self-efficacy and adherence to treatment.^9-11Adding supplemental oxygen has been shown to improve longevity, and may help boost mood and lessen anxiety in some patients, whereas others find its restrictions burdensome and demoralizing.⁸ Pulmonary rehabilitation programs are a key component of both secondary prevention and treatment in improving overall health outcomes in patients with COPD,¹² and can be started at any stage of the illness. However, patients with comorbid anxiety and depression are often the least likely to engage in these programs.^4,13 One program that offered management of depression and COPD care with a focus on misconceptions about treatment and obstacles to treatment engagement reduced depressive symptoms and dyspnea-related disability, which led to greater remission of depression.^14,15 Exercise training in such programs also helps manage avoidance of physical activity due to fear of dyspnea by allowing patients to experience feared symptoms in the presence of medical professionals, similar to the CBT interoceptive exposure technique described earlier.¹ Several traditional treatment modalities used to target Ms. M’s anxiety disorder were unsuccessful. Low-dose, as-needed opioids are a safe and useful pharmacologic option worth considering for patients with refractory anxiety and depression and comorbid COPD.

Bottom Line

When traditional antidepressant and anxiolytic therapies have not sufficiently helped, consider low-dose, once-daily opioids to address refractory breathlessness in a patient with COPD with comorbid anxiety and depression. This treatment can lead patients to participate in rehabilitation therapies and improve their quality of life.

Related Resources

• Alexopoulos G, Kiosses D, Sirey J, et al. Untangling therapeutic ingredients of a personalized intervention for patients with depression and severe COPD. Am J Geriatr Psychiatry. 2014;22(11):1316-1324.
• Jackson D, Banerjee S, Sirey J, et al. Two interventions for patients with major depression and severe chronic obstructive pulmonary disease: impact on quality of life. Am J Geriatr Psychiatry. 2018;27(5):502-511.

Drug Brand Names

Amlodipine • Norvasc
Aripiprazole • Abilify
Buspirone • Buspar
Clonazepam • Klonopin
Duloxetine • Cymbalta
Fluoxetine • Prozac
Hydromorphone • Dilaudid
Levodopa • Sinemet
Lorazepam • Ativan
Mirtazapine • Remeron
Morphine • MS Contin
Naloxone • Narcan
Oxycodone • Oxycontin
Salmeterol • Serevent Diskus

CASE A passive wish to die

Ms. M, age 76, has a history of major depressive disorder, unspecified anxiety disorder, and severe chronic obstructive pulmonary disease (COPD), for which she requires supplemental oxygen. She is admitted to a psychiatric hospital after several months of increased dysphoria, rumination, anhedonia, and a passive wish to die. She also has a decreased appetite and has lost 10 lb, experiences frequent daily episodes of shortness of breath and associated racing thoughts, and has a rapid heart rate.

HISTORY Past medication trials

In addition to COPD, Ms. M’s medical history includes hypertension. Past psychotropic medication trials used to treat her depression and anxiety have included aripiprazole, 5 mg/d; duloxetine, 60 mg/d; fluoxetine, 40 mg/d; mirtazapine, 30 mg nightly; buspirone, 10 mg twice daily; and clonazepam, 0.5 mg twice daily. She has no history of psychotherapy, and because of her uncontrolled anxiety and depression, she has never completed a pulmonary rehabilitation program.

Her current medications include salmeterol, 50 mcg inhaled twice daily, for COPD; amlodipine, 10 mg/d, for hypertension; buspirone, 10 mg twice daily, for anxiety; and duloxetine, 60 mg/d, for depression.

EXAMINATION No evidence of dementia

On examination, Ms. M is alert and oriented to person, place, date, and situation. Overall, she has mild difficulty with attention and short-term recall, which appears to be due to poor effort; intact long-term memory; and is able to abstract appropriately. There is no evidence of dementia.

A mental status exam reveals a frail, elderly woman with fair-to-poor hygiene, cooperative behavior, slowed motor activity, slowed speech with low volume, low mood, and depressed affect with constricted range. Her thought process is linear, her thought content includes passive death wishes, and she does not have hallucinations.

Bitemporal electroconvulsive therapy (ECT), 1.0 ms pulse width at 1.5 times Ms. M’s seizure threshold 3 times weekly, is initiated to treat her depression, with seizure duration averaging 45 seconds for each session. She receives a total of 8 treatments over the course of admission. Buspirone, 10 mg twice daily, is stopped shortly after admission, but she continues to receive duloxetine, 60 mg/d. Ms. M continues to have shortness of breath, palpitations, fearful ruminations about the future, and difficulty falling asleep.

[polldaddy:10673878]

The authors’ observations

The treatment team explores other options, such as benzodiazepines, psychotherapy modalities, and mindfulness exercises, to treat Ms. M’s anxiety and comorbid COPD. Lorazepam, 0.5 mg twice daily, was chosen to treat her acute anxiety. Due to Ms. M’s need for supplemental oxygen, the treatment team attempted to mitigate the risk of using a benzodiazepine by limiting its use to the minimum effective dose. The teams also looked for alternative therapies.

Continue to: Evalution of anxiety...

Evaluation of anxiety and depression in a patient with COPD is complicated by a high degree of symptom overlap. Patients with COPD may experience anxiety symptoms such as shortness of breath, rapid heart rate, numbness/tingling, and racing thoughts, and/or depressive symptoms such as decreased energy, impaired sleep, and impaired concentration. It can therefore be difficult to discern if a symptom is attributable to the physical diagnosis, the psychiatric diagnosis, or a combination of both. Catastrophic thinking about mild physical symptoms is common in patients with COPD. This can lead to hyperventilation and hypocapnia (manifested by lightheadedness, dizziness, paresthesia, and altered consciousness), with a reciprocally escalating cascade of anxiety and somatic symptoms.¹

First-line therapy for anxiety disorders with comorbid COPD is CBT and other nonpharmacologic interventions.^2,3However, access to CBT-trained psychotherapists is limited due to the cost and a shortage of qualified professionals.⁴ One randomized clinical trial evaluated improving accessibility to this therapy by training respiratory therapists to perform CBT sessions for COPD patients who were anxious and depressed.⁴ This method was as successful as using CBT-trained psychotherapists, and also reduced emergency room visits and hospitalizations in this population.⁴ Respiratory therapists often intuitively use CBT concepts in coaching patients and generally have the knowledge and background to be able to help patients identify symptoms caused by anxiety vs when to seek additional medical support. Furthermore, these interventions have been shown to increase quality-adjusted life years,⁴ improve physical performance, and reduce symptoms of anxiety and depression as reported on the Beck Anxiety Inventory and Beck Depression Inventory.⁵ In addition to relaxation/imagery training, cognitive restructuring, breathing retraining, and maintaining daily symptom logs, CBT for COPD may include interoceptive exposure therapy. This technique involves deliberately inducing hyperventilation, followed by desensitization exercises to uncouple any uncomfortable physical sensations with the conditioned fear response.¹

Although there is little evidence that traditional pharmacologic treatments (eg, antidepressants, benzodiazepines) have a statistically significant effect on anxiety and depression in COPD, studies have found that they have some clinical benefit.³ Risks, however, limit the utility of certain agents. Sedative-hypnotics potentially decrease respiratory drive and, particularly in older patients, antidepressants’ sedating effects can increase the risk of falls³ leading to increased morbidity, hospitalization, and mortality.

TREATMENT Mindfulness techniques and meditation

Ms. M’s symptoms show no improvement with the addition of lorazepam, 0.5 mg twice daily. A clinician teaches Ms. M mindfulness techniques, and she begins a trial of daily, individual, guided meditation using a meditation app. Respiratory therapists also instruct her on controlled breathing techniques such as pursed-lips breathing, diaphragmatic breathing, and deep breathing. They also encourage Ms. M to participate in the daily exercise group while on the unit.

[polldaddy:10673881]

The authors’ observations

Research indicates that low doses of opioids are safe and effective for refractory breathlessness in patients with severe COPD(those with an arterial partial pressure of oxygen ≤55 mm Hg or arterial oxygen saturation ≤88%).^6,7 Patients at this advanced stage of illness have likely been started on oxygen therapy to improve survival but may need additional palliative measures to alleviate the discomfort associated with the severe breathlessness experienced at this stage.⁸ In such situations, low-dose opioids, such as immediate-release morphine, 1 mg/d given as 0.5 mg twice daily, can be started.⁸ The dose can be increased by 0.5 mg until a therapeutic dose is achieved.⁸ Alternately, 24-hour extended-release morphine, 20 mg/d, or an equivalent dose of oxycodone or hydromorphone, can be prescribed.⁸ The proposed therapeutic mechanisms of low-dose opioids for these patients include decreasing one’s sense of effort, altering central perception, altering activity of peripheral opioid receptors located in the lung, and decreasing anxiety.⁸

Continue to: The current opioid crisis...

The current opioid crisis prompts additional caution in prescribing, especially when considering using short-acting, immediate-release opioids such as morphine, which have a greater potential for abuse and dependence. The Table lists safeguards that should be implemented when prescribing opioids.

Many patients with COPD in the end-of-life phase and in severe pain or discomfort due to the advanced stages of their illness receive opioids as part of palliative care. Patients with COPD whose medical care is predominantly palliative may benefit greatly from being prescribed opioids. Most patients with COPD who find relief from low-dose opioids usually have 6 to 12 months to live, and low-dose opioids may help them obtain the best possible quality of life.

Choosing opioids as a treatment involves the risk of physiologic dependence and opioid use disorder. For Ms. M, the potential benefits were thought to outweigh such risks.

OUTCOME Breathlessness improves, anxiety decreases

Ms. M’s lorazepam is discontinued, and immediate-release morphine is prescribed at a low dose of 1 mg/d on an as-needed basis for anxiety with good effect. Ms. M’s breathlessness improves, leading to an overall decrease in anxiety. She does not experience sedation, confusion, or adverse respiratory effects.

Ms. M’s anxiety and depression improve over the course of the hospitalization with this regimen. On hospital Day 25, she is discharged with a plan to continue duloxetine, 60 mg/d, ECT twice weekly, and low-dose morphine, 1 mg/d, as needed for anxiety. She is referred for pulmonary rehabilitation and CBT to maintain remission.

[polldaddy:10673882]

Continue to: The authors' observations

Ms. M’s case highlights several challenges associated with treating psychiatric illness in a patient with a chronic medical illness. The relationship between COPD, anxiety, and depression is complex, and is associated with reduced quality of life, increasing severity of pulmonary disease, increased dyspnea, a sense of loss and inability to cope, and decreased self-efficacy and adherence to treatment.^9-11Adding supplemental oxygen has been shown to improve longevity, and may help boost mood and lessen anxiety in some patients, whereas others find its restrictions burdensome and demoralizing.⁸ Pulmonary rehabilitation programs are a key component of both secondary prevention and treatment in improving overall health outcomes in patients with COPD,¹² and can be started at any stage of the illness. However, patients with comorbid anxiety and depression are often the least likely to engage in these programs.^4,13 One program that offered management of depression and COPD care with a focus on misconceptions about treatment and obstacles to treatment engagement reduced depressive symptoms and dyspnea-related disability, which led to greater remission of depression.^14,15 Exercise training in such programs also helps manage avoidance of physical activity due to fear of dyspnea by allowing patients to experience feared symptoms in the presence of medical professionals, similar to the CBT interoceptive exposure technique described earlier.¹ Several traditional treatment modalities used to target Ms. M’s anxiety disorder were unsuccessful. Low-dose, as-needed opioids are a safe and useful pharmacologic option worth considering for patients with refractory anxiety and depression and comorbid COPD.

Bottom Line

When traditional antidepressant and anxiolytic therapies have not sufficiently helped, consider low-dose, once-daily opioids to address refractory breathlessness in a patient with COPD with comorbid anxiety and depression. This treatment can lead patients to participate in rehabilitation therapies and improve their quality of life.

Related Resources

• Alexopoulos G, Kiosses D, Sirey J, et al. Untangling therapeutic ingredients of a personalized intervention for patients with depression and severe COPD. Am J Geriatr Psychiatry. 2014;22(11):1316-1324.
• Jackson D, Banerjee S, Sirey J, et al. Two interventions for patients with major depression and severe chronic obstructive pulmonary disease: impact on quality of life. Am J Geriatr Psychiatry. 2018;27(5):502-511.

Drug Brand Names

Amlodipine • Norvasc
Aripiprazole • Abilify
Buspirone • Buspar
Clonazepam • Klonopin
Duloxetine • Cymbalta
Fluoxetine • Prozac
Hydromorphone • Dilaudid
Levodopa • Sinemet
Lorazepam • Ativan
Mirtazapine • Remeron
Morphine • MS Contin
Naloxone • Narcan
Oxycodone • Oxycontin
Salmeterol • Serevent Diskus

As a psychiatry resident in the age of coronavirus disease 2019 (COVID-19), many of my educational experiences have undergone adjustments. Now, as I interview for a fellowship, I see firsthand that recruitment activities have not been spared from shifting paradigms levied by the pandemic. To adhere to social distancing guidelines and limit trainee interpersonal exposure, the American Association of Directors of Psychiatric Residency Training recommended that all psychiatry residency interviews be conducted virtually for 2020/2021.¹ Trainees and programs alike are embarking on a new frontier of virtual interviews, and it is important that we evaluate the advantages and disadvantages of this approach. Because uncertainty abounds regarding when a sense of normalcy might eventually return to psychiatry residency and fellowship recruitment activities, I also provide recommendations to interviewers and interviewees who may navigate virtual recruitment in the future.

Advantages of virtual interviews

An immediately significant advantage of virtual interviews is the lack of travel, which for some applicants can be cost-prohibitive. The costs of airfare, rental vehicles, and lodging in multiple cities can add up, sometimes requiring students to budget interview travel into already-high student loans. In some cases, applicants may have limited days to interview, which makes the flexibility afforded by the lack of travel advantageous. Furthermore, navigating new locations can add to preexisting interview stress. Without travel, applicants can consider a broader set of programs and accept more interviews.

Another advantage is that virtual interviews allow interviewees latitude to shift the interview’s “frame.” Rather than sitting in an interviewer’s office, interviewees can choose a more comfortable environment for themselves, imparting a “home-field advantage” that may put them at ease. During my fellowship interviews, controlling the room temperature, using a familiar chair, and wearing comfortable shoes helped to reduce the anxiety inherent to interviewing.

Disadvantages of virtual interviews

Any new or unfamiliar experience can impart challenges. For example, applicants and interviewers must adjust to and observe different sets of etiquette during virtual interviews. These include muting microphones to avoid talking over each other, maintaining consistent eye contact, avoiding multitasking, and following up to avoid miscommunication.

Another potential problem is that virtual interviews can dampen an applicant’s ability to appreciate a program’s culture. Observing informal interactions between trainees and faculty is often as important as the formal interviews in ascertaining which programs have a supportive culture. Because my virtual fellowship interviews have generally been limited to formal one-on-one interviews, assessing program culture has become more challenging. Conversely, programs may find it difficult to grasp an applicant’s temperament and interaction style.

Virtual interviewing, while undeniably convenient in many regards, may fall prey to its own convenience. There can be disparities in the quantity, duration, and frequency of interviews. For me, the number of and time allotted for interviews has varied widely, ranging from 2.5 to 8 hours. The amount of allotted break time has also differed, with some programs providing longer breaks between interviews (30 to 60 minutes) and others offering shorter (5 to 10 minutes) or no breaks. Minimal breaks may fatigue applicants, while longer breaks may seem like wasted time. While virtual interviews may require no physical travel between offices, breaks are a necessity that should be implemented thoughtfully.

Finally, a troublesome challenge I encountered surprisingly often was unreliable internet service and other technical difficulties. Several times, my interviewers’ (or my) screen froze or shut off due to connectivity issues. This is an obstacle unique to virtual interviews that requires both a backup plan as well as patience and calm to navigate during an already taxing situation.

Continue to: What's next?

What’s next?

As applicants and programs adjust to the realities of virtual interviewing, this is likely an unfamiliar experience for all. While the benefits and shortcomings must be considered together, I, along with many of my peers,² continue to prefer traditional in-person interviews. As the ongoing COVID-19 pandemic makes in-person interviews difficult, applicants and programs must embrace the experience of virtual interviews. However, a good understanding of the advantages and disadvantages are instrumental in preempting prospective challenges. Based on my recent experiences with virtual fellowship interviews, I have created some recommendations for applicants and psychiatry programs participating in virtual recruitment (Table).

After the COVID-19 pandemic subsides, it is conceivable that the advantages of virtual interviewing may justify its continued use. For example, applicants may be able to apply to geographically diverse programs without travel expenses. Currently, there is a paucity of evidence regarding virtual interviews specifically in psychiatry training programs, but the experiences of both applicants and psychiatry programs during this atypical time will allow us to improve the process going forward, and evaluate its utility well after COVID-19 recedes.

As a psychiatry resident in the age of coronavirus disease 2019 (COVID-19), many of my educational experiences have undergone adjustments. Now, as I interview for a fellowship, I see firsthand that recruitment activities have not been spared from shifting paradigms levied by the pandemic. To adhere to social distancing guidelines and limit trainee interpersonal exposure, the American Association of Directors of Psychiatric Residency Training recommended that all psychiatry residency interviews be conducted virtually for 2020/2021.¹ Trainees and programs alike are embarking on a new frontier of virtual interviews, and it is important that we evaluate the advantages and disadvantages of this approach. Because uncertainty abounds regarding when a sense of normalcy might eventually return to psychiatry residency and fellowship recruitment activities, I also provide recommendations to interviewers and interviewees who may navigate virtual recruitment in the future.

Advantages of virtual interviews

An immediately significant advantage of virtual interviews is the lack of travel, which for some applicants can be cost-prohibitive. The costs of airfare, rental vehicles, and lodging in multiple cities can add up, sometimes requiring students to budget interview travel into already-high student loans. In some cases, applicants may have limited days to interview, which makes the flexibility afforded by the lack of travel advantageous. Furthermore, navigating new locations can add to preexisting interview stress. Without travel, applicants can consider a broader set of programs and accept more interviews.

Another advantage is that virtual interviews allow interviewees latitude to shift the interview’s “frame.” Rather than sitting in an interviewer’s office, interviewees can choose a more comfortable environment for themselves, imparting a “home-field advantage” that may put them at ease. During my fellowship interviews, controlling the room temperature, using a familiar chair, and wearing comfortable shoes helped to reduce the anxiety inherent to interviewing.

Disadvantages of virtual interviews

Any new or unfamiliar experience can impart challenges. For example, applicants and interviewers must adjust to and observe different sets of etiquette during virtual interviews. These include muting microphones to avoid talking over each other, maintaining consistent eye contact, avoiding multitasking, and following up to avoid miscommunication.

Another potential problem is that virtual interviews can dampen an applicant’s ability to appreciate a program’s culture. Observing informal interactions between trainees and faculty is often as important as the formal interviews in ascertaining which programs have a supportive culture. Because my virtual fellowship interviews have generally been limited to formal one-on-one interviews, assessing program culture has become more challenging. Conversely, programs may find it difficult to grasp an applicant’s temperament and interaction style.

Virtual interviewing, while undeniably convenient in many regards, may fall prey to its own convenience. There can be disparities in the quantity, duration, and frequency of interviews. For me, the number of and time allotted for interviews has varied widely, ranging from 2.5 to 8 hours. The amount of allotted break time has also differed, with some programs providing longer breaks between interviews (30 to 60 minutes) and others offering shorter (5 to 10 minutes) or no breaks. Minimal breaks may fatigue applicants, while longer breaks may seem like wasted time. While virtual interviews may require no physical travel between offices, breaks are a necessity that should be implemented thoughtfully.

Finally, a troublesome challenge I encountered surprisingly often was unreliable internet service and other technical difficulties. Several times, my interviewers’ (or my) screen froze or shut off due to connectivity issues. This is an obstacle unique to virtual interviews that requires both a backup plan as well as patience and calm to navigate during an already taxing situation.

Continue to: What's next?

What’s next?

As applicants and programs adjust to the realities of virtual interviewing, this is likely an unfamiliar experience for all. While the benefits and shortcomings must be considered together, I, along with many of my peers,² continue to prefer traditional in-person interviews. As the ongoing COVID-19 pandemic makes in-person interviews difficult, applicants and programs must embrace the experience of virtual interviews. However, a good understanding of the advantages and disadvantages are instrumental in preempting prospective challenges. Based on my recent experiences with virtual fellowship interviews, I have created some recommendations for applicants and psychiatry programs participating in virtual recruitment (Table).

After the COVID-19 pandemic subsides, it is conceivable that the advantages of virtual interviewing may justify its continued use. For example, applicants may be able to apply to geographically diverse programs without travel expenses. Currently, there is a paucity of evidence regarding virtual interviews specifically in psychiatry training programs, but the experiences of both applicants and psychiatry programs during this atypical time will allow us to improve the process going forward, and evaluate its utility well after COVID-19 recedes.

As a psychiatry resident in the age of coronavirus disease 2019 (COVID-19), many of my educational experiences have undergone adjustments. Now, as I interview for a fellowship, I see firsthand that recruitment activities have not been spared from shifting paradigms levied by the pandemic. To adhere to social distancing guidelines and limit trainee interpersonal exposure, the American Association of Directors of Psychiatric Residency Training recommended that all psychiatry residency interviews be conducted virtually for 2020/2021.¹ Trainees and programs alike are embarking on a new frontier of virtual interviews, and it is important that we evaluate the advantages and disadvantages of this approach. Because uncertainty abounds regarding when a sense of normalcy might eventually return to psychiatry residency and fellowship recruitment activities, I also provide recommendations to interviewers and interviewees who may navigate virtual recruitment in the future.

Advantages of virtual interviews

An immediately significant advantage of virtual interviews is the lack of travel, which for some applicants can be cost-prohibitive. The costs of airfare, rental vehicles, and lodging in multiple cities can add up, sometimes requiring students to budget interview travel into already-high student loans. In some cases, applicants may have limited days to interview, which makes the flexibility afforded by the lack of travel advantageous. Furthermore, navigating new locations can add to preexisting interview stress. Without travel, applicants can consider a broader set of programs and accept more interviews.

Another advantage is that virtual interviews allow interviewees latitude to shift the interview’s “frame.” Rather than sitting in an interviewer’s office, interviewees can choose a more comfortable environment for themselves, imparting a “home-field advantage” that may put them at ease. During my fellowship interviews, controlling the room temperature, using a familiar chair, and wearing comfortable shoes helped to reduce the anxiety inherent to interviewing.

Disadvantages of virtual interviews

Any new or unfamiliar experience can impart challenges. For example, applicants and interviewers must adjust to and observe different sets of etiquette during virtual interviews. These include muting microphones to avoid talking over each other, maintaining consistent eye contact, avoiding multitasking, and following up to avoid miscommunication.

Another potential problem is that virtual interviews can dampen an applicant’s ability to appreciate a program’s culture. Observing informal interactions between trainees and faculty is often as important as the formal interviews in ascertaining which programs have a supportive culture. Because my virtual fellowship interviews have generally been limited to formal one-on-one interviews, assessing program culture has become more challenging. Conversely, programs may find it difficult to grasp an applicant’s temperament and interaction style.

Virtual interviewing, while undeniably convenient in many regards, may fall prey to its own convenience. There can be disparities in the quantity, duration, and frequency of interviews. For me, the number of and time allotted for interviews has varied widely, ranging from 2.5 to 8 hours. The amount of allotted break time has also differed, with some programs providing longer breaks between interviews (30 to 60 minutes) and others offering shorter (5 to 10 minutes) or no breaks. Minimal breaks may fatigue applicants, while longer breaks may seem like wasted time. While virtual interviews may require no physical travel between offices, breaks are a necessity that should be implemented thoughtfully.

Finally, a troublesome challenge I encountered surprisingly often was unreliable internet service and other technical difficulties. Several times, my interviewers’ (or my) screen froze or shut off due to connectivity issues. This is an obstacle unique to virtual interviews that requires both a backup plan as well as patience and calm to navigate during an already taxing situation.

Continue to: What's next?

What’s next?

As applicants and programs adjust to the realities of virtual interviewing, this is likely an unfamiliar experience for all. While the benefits and shortcomings must be considered together, I, along with many of my peers,² continue to prefer traditional in-person interviews. As the ongoing COVID-19 pandemic makes in-person interviews difficult, applicants and programs must embrace the experience of virtual interviews. However, a good understanding of the advantages and disadvantages are instrumental in preempting prospective challenges. Based on my recent experiences with virtual fellowship interviews, I have created some recommendations for applicants and psychiatry programs participating in virtual recruitment (Table).

After the COVID-19 pandemic subsides, it is conceivable that the advantages of virtual interviewing may justify its continued use. For example, applicants may be able to apply to geographically diverse programs without travel expenses. Currently, there is a paucity of evidence regarding virtual interviews specifically in psychiatry training programs, but the experiences of both applicants and psychiatry programs during this atypical time will allow us to improve the process going forward, and evaluate its utility well after COVID-19 recedes.

As the world grapples with the coronavirus disease 2019 (COVID-19) pandemic, the search for answers, comfort, how to cope, and how to make sense of it all has become paramount. People commonly turn to their faith in times of crisis, but this recent global public health emergency is unlike many have ever seen or could have imagined.¹ What happens when the well-intentioned journey for spiritual insight intersects with psychiatric symptomatology? Where does the line between these phenomena get crossed? As a psychiatric resident and person who was raised in the Pentecostal faith, I have observed faith and psychopathology come to a head in the last 6 months. COVID-19 has dealt a religious strain of undocumented cases; I hope to shed light on the topic by sharing my experience of navigating the assessment and treatment plan of patients with psychiatric symptoms whose spiritual beliefs are a cornerstone of life.

Piety, or pathology?

The following approaches have helped me to identify what is driven by faith vs what is psychopathology:

While taking the patient history. Obtaining a history from a patient who professes to have strong spiritual beliefs and presents with psychiatric symptoms is similar to a standard patient interview, but pay special attention to how the patient came to the emergency department. Was there a family member, friend, or emergency medical services present at that time? During the interview, patients often appear “normal,” which may lead a clinician to question the reason for the consult, yet considering the recent events preceding the presentation will be a good place to start gathering the appropriate information for investigation.

Next, compare the patient’s recent daily functioning with his/her baseline. If this information comes solely from the patient, it may be skewed, so try to retrieve information from a collateral source. If the patient was accompanied by someone, request permission from the patient to speak with him/her. It may also be best in some instances to speak with the collateral source out of earshot of the patient. Be aware that collateral information that comes from just one source also could be biased, so search for additional contacts to help acquire a comprehensive representation of the circumstances.

Information about a patient could come from a faith leader because people often rely on their faith leaders when they are ill, in need of support, or in crisis.² Faith leaders may have valuable information and insight into the patient and the history of the patient’s illness. In addition, diverse sources of collateral reports may be helpful because specific spiritual views and practices can vary even within one family or congregation. What may be an abnormal practice to some followers may be normal for others.³ When approaching these situations with parishioners, it is essential to maintain confidentiality.

While performing the clinical examination. As with any psychiatric diagnosis, other causative factors (metabolic and organic) need to be ruled out. Also, assess for the use of mood-altering substances. The patient may express offense or resistance to such questions, but maintain a matter-of-fact approach and explain that assessment for substance use is a routine part of the clinical examination. Approximately 18% of people in the United States with psychiatric disorders have a comorbid substance use disorder.⁴ However, keep in mind that a patient who refuses substance use screening is not necessarily hiding something. The road to being thorough may lead to strained rapport with the patient, and this risk must be balanced with providing the best care. As in any other clinical situation, seek evidence to both verify and clarify information without being deterred by a patient’s vocalization of spiritual tenants.

Learn about your patients’ beliefs

Do not feel defeated if you find these interviews difficult. Religion and symptomatology can overlap and fluctuate within the same faith group, which can make these types of assessments complex.⁵ In an effort to understand the patient more clearly, be sensitive to their spiritual practices and receptive to learning about unfamiliar spiritual beliefs. Be transparent about not knowing a specific belief or practice, and exhibit humility. Most patients are open to sharing their religious/spiritual views with a clinician who is sincere about wanting insight. Understanding the value of spiritual care is an important skill that many medical practitioners often lack.⁶ This understanding is especially critical when patients express worries related to the COVID-19 pandemic and how they are coping.

Continue to: Integrate your patient's spiritual requests

If you are comfortable with certain practices that do not compromise your values or beliefs or put a patient at risk, try to integrate your patients’ spiritual request(s) in their care. For a patient who serves a higher power, admitting to a problem (eg, fears related to COVID-19) or seeking professional help for symptoms (eg, anxiety, depression) may imply spiritual doubt. Patients may believe that seeking professional assistance means they are questioning the omnipotence of their deity to prevent or heal a condition. While spiritual distress can stimulate changes in behavior, it may not be pathological.

To avoid misdiagnosis, refer to the description “V62.89 (Z65.8) Religious or Spiritual Problem” in the DSM-5.⁷ If you find that it is a discord in faith that is affecting the patient’s presentation, and that this has not caused a psychiatric disorder, document this appropriately and provide the necessary resources to continue supporting the patient holistically.

As the world grapples with the coronavirus disease 2019 (COVID-19) pandemic, the search for answers, comfort, how to cope, and how to make sense of it all has become paramount. People commonly turn to their faith in times of crisis, but this recent global public health emergency is unlike many have ever seen or could have imagined.¹ What happens when the well-intentioned journey for spiritual insight intersects with psychiatric symptomatology? Where does the line between these phenomena get crossed? As a psychiatric resident and person who was raised in the Pentecostal faith, I have observed faith and psychopathology come to a head in the last 6 months. COVID-19 has dealt a religious strain of undocumented cases; I hope to shed light on the topic by sharing my experience of navigating the assessment and treatment plan of patients with psychiatric symptoms whose spiritual beliefs are a cornerstone of life.

Piety, or pathology?

The following approaches have helped me to identify what is driven by faith vs what is psychopathology:

While taking the patient history. Obtaining a history from a patient who professes to have strong spiritual beliefs and presents with psychiatric symptoms is similar to a standard patient interview, but pay special attention to how the patient came to the emergency department. Was there a family member, friend, or emergency medical services present at that time? During the interview, patients often appear “normal,” which may lead a clinician to question the reason for the consult, yet considering the recent events preceding the presentation will be a good place to start gathering the appropriate information for investigation.

Next, compare the patient’s recent daily functioning with his/her baseline. If this information comes solely from the patient, it may be skewed, so try to retrieve information from a collateral source. If the patient was accompanied by someone, request permission from the patient to speak with him/her. It may also be best in some instances to speak with the collateral source out of earshot of the patient. Be aware that collateral information that comes from just one source also could be biased, so search for additional contacts to help acquire a comprehensive representation of the circumstances.

Information about a patient could come from a faith leader because people often rely on their faith leaders when they are ill, in need of support, or in crisis.² Faith leaders may have valuable information and insight into the patient and the history of the patient’s illness. In addition, diverse sources of collateral reports may be helpful because specific spiritual views and practices can vary even within one family or congregation. What may be an abnormal practice to some followers may be normal for others.³ When approaching these situations with parishioners, it is essential to maintain confidentiality.

While performing the clinical examination. As with any psychiatric diagnosis, other causative factors (metabolic and organic) need to be ruled out. Also, assess for the use of mood-altering substances. The patient may express offense or resistance to such questions, but maintain a matter-of-fact approach and explain that assessment for substance use is a routine part of the clinical examination. Approximately 18% of people in the United States with psychiatric disorders have a comorbid substance use disorder.⁴ However, keep in mind that a patient who refuses substance use screening is not necessarily hiding something. The road to being thorough may lead to strained rapport with the patient, and this risk must be balanced with providing the best care. As in any other clinical situation, seek evidence to both verify and clarify information without being deterred by a patient’s vocalization of spiritual tenants.

Learn about your patients’ beliefs

Do not feel defeated if you find these interviews difficult. Religion and symptomatology can overlap and fluctuate within the same faith group, which can make these types of assessments complex.⁵ In an effort to understand the patient more clearly, be sensitive to their spiritual practices and receptive to learning about unfamiliar spiritual beliefs. Be transparent about not knowing a specific belief or practice, and exhibit humility. Most patients are open to sharing their religious/spiritual views with a clinician who is sincere about wanting insight. Understanding the value of spiritual care is an important skill that many medical practitioners often lack.⁶ This understanding is especially critical when patients express worries related to the COVID-19 pandemic and how they are coping.

Continue to: Integrate your patient's spiritual requests

If you are comfortable with certain practices that do not compromise your values or beliefs or put a patient at risk, try to integrate your patients’ spiritual request(s) in their care. For a patient who serves a higher power, admitting to a problem (eg, fears related to COVID-19) or seeking professional help for symptoms (eg, anxiety, depression) may imply spiritual doubt. Patients may believe that seeking professional assistance means they are questioning the omnipotence of their deity to prevent or heal a condition. While spiritual distress can stimulate changes in behavior, it may not be pathological.

To avoid misdiagnosis, refer to the description “V62.89 (Z65.8) Religious or Spiritual Problem” in the DSM-5.⁷ If you find that it is a discord in faith that is affecting the patient’s presentation, and that this has not caused a psychiatric disorder, document this appropriately and provide the necessary resources to continue supporting the patient holistically.

As the world grapples with the coronavirus disease 2019 (COVID-19) pandemic, the search for answers, comfort, how to cope, and how to make sense of it all has become paramount. People commonly turn to their faith in times of crisis, but this recent global public health emergency is unlike many have ever seen or could have imagined.¹ What happens when the well-intentioned journey for spiritual insight intersects with psychiatric symptomatology? Where does the line between these phenomena get crossed? As a psychiatric resident and person who was raised in the Pentecostal faith, I have observed faith and psychopathology come to a head in the last 6 months. COVID-19 has dealt a religious strain of undocumented cases; I hope to shed light on the topic by sharing my experience of navigating the assessment and treatment plan of patients with psychiatric symptoms whose spiritual beliefs are a cornerstone of life.

Piety, or pathology?

The following approaches have helped me to identify what is driven by faith vs what is psychopathology:

While taking the patient history. Obtaining a history from a patient who professes to have strong spiritual beliefs and presents with psychiatric symptoms is similar to a standard patient interview, but pay special attention to how the patient came to the emergency department. Was there a family member, friend, or emergency medical services present at that time? During the interview, patients often appear “normal,” which may lead a clinician to question the reason for the consult, yet considering the recent events preceding the presentation will be a good place to start gathering the appropriate information for investigation.

Next, compare the patient’s recent daily functioning with his/her baseline. If this information comes solely from the patient, it may be skewed, so try to retrieve information from a collateral source. If the patient was accompanied by someone, request permission from the patient to speak with him/her. It may also be best in some instances to speak with the collateral source out of earshot of the patient. Be aware that collateral information that comes from just one source also could be biased, so search for additional contacts to help acquire a comprehensive representation of the circumstances.

Information about a patient could come from a faith leader because people often rely on their faith leaders when they are ill, in need of support, or in crisis.² Faith leaders may have valuable information and insight into the patient and the history of the patient’s illness. In addition, diverse sources of collateral reports may be helpful because specific spiritual views and practices can vary even within one family or congregation. What may be an abnormal practice to some followers may be normal for others.³ When approaching these situations with parishioners, it is essential to maintain confidentiality.

While performing the clinical examination. As with any psychiatric diagnosis, other causative factors (metabolic and organic) need to be ruled out. Also, assess for the use of mood-altering substances. The patient may express offense or resistance to such questions, but maintain a matter-of-fact approach and explain that assessment for substance use is a routine part of the clinical examination. Approximately 18% of people in the United States with psychiatric disorders have a comorbid substance use disorder.⁴ However, keep in mind that a patient who refuses substance use screening is not necessarily hiding something. The road to being thorough may lead to strained rapport with the patient, and this risk must be balanced with providing the best care. As in any other clinical situation, seek evidence to both verify and clarify information without being deterred by a patient’s vocalization of spiritual tenants.

Learn about your patients’ beliefs

Do not feel defeated if you find these interviews difficult. Religion and symptomatology can overlap and fluctuate within the same faith group, which can make these types of assessments complex.⁵ In an effort to understand the patient more clearly, be sensitive to their spiritual practices and receptive to learning about unfamiliar spiritual beliefs. Be transparent about not knowing a specific belief or practice, and exhibit humility. Most patients are open to sharing their religious/spiritual views with a clinician who is sincere about wanting insight. Understanding the value of spiritual care is an important skill that many medical practitioners often lack.⁶ This understanding is especially critical when patients express worries related to the COVID-19 pandemic and how they are coping.

Continue to: Integrate your patient's spiritual requests

If you are comfortable with certain practices that do not compromise your values or beliefs or put a patient at risk, try to integrate your patients’ spiritual request(s) in their care. For a patient who serves a higher power, admitting to a problem (eg, fears related to COVID-19) or seeking professional help for symptoms (eg, anxiety, depression) may imply spiritual doubt. Patients may believe that seeking professional assistance means they are questioning the omnipotence of their deity to prevent or heal a condition. While spiritual distress can stimulate changes in behavior, it may not be pathological.

To avoid misdiagnosis, refer to the description “V62.89 (Z65.8) Religious or Spiritual Problem” in the DSM-5.⁷ If you find that it is a discord in faith that is affecting the patient’s presentation, and that this has not caused a psychiatric disorder, document this appropriately and provide the necessary resources to continue supporting the patient holistically.

A healthy dose of skepticism is reasonable when evaluating new technologies to potentially use in your practice, but being overly critical can backfire, according to E. Victor Ross, MD.

During a virtual course on laser and aesthetic skin therapy, he noted that dermatologists may be evaluating new technologies in roles as an investigator or provider, or as a provider who buys the equipment outright, without any direct compensation from industry. “If you’re doing investigative work, you’re already in a conflicted situation because you’re trying to serve two masters,” said Dr. Ross, who directs the Scripps Clinic Laser and Cosmetic Dermatology Center in San Diego. “You’re trying to advance science and to make sure your reputation is intact and maybe even enhanced, but you’re also kind of at the whim of industry, because they have a goal. Sometimes the goals are similar. Your goal is to advance the technology and advance patient care, but they have a goal of selling equipment. Those goals should be compatible, and they should be in the same pathway; they should be parallel.”

Being too critical as an investigator/researcher of new technologies can hinder further interactions with industry. “Sometimes your criticism can be premature, and small changes in the technology and/or waiting for results can validate the technology,” he said. “Maybe it’s a skin-tightening technology, or maybe there’s something you don’t like about it; you have a prototype and you say: ‘This is not so great,’ but these are studies that take a long time to evaluate, like hair removal. Generally, if you’re a big critic, after a while, nobody wants to hear it. So, you can’t be overly critical. I think you can be skeptical, but not overly critical.”

On the other hand, Dr. Ross continued, if you cheerlead for the device industry, your reputation may be sold to the highest bidder. “You may compromise your ability to be trusted in future work or presentations. I’ve regretted some things I said many years ago, not because I was being dishonest but because I really wasn’t as skeptical as I should have been about the types of results I was getting. You do tend to get on a bandwagon; you want everything to be positive,” he said, adding: “The other thing that can happen is, if things don’t work out with other buyers, they’re going to say, ‘I can’t get the same results.’ If somebody can’t replicate what you’re doing, it’s going to put your reputation on the line to some degree. So, you have to be very careful.”

Before agreeing to evaluate a new technology as an investigator or in your own practice, Dr. Ross recommended asking yourself if the intervention makes sense on a gross or microanatomic level. “There should be a physical basis for how it works, and ideally there should be some histology that backs it up,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Where is the data to support the outcomes? If it is your own data, how skeptical have you been in its acquisition and assessment?”

When evaluating a new technology, Dr. Ross recommended starting with test spots and low settings. “It behooves you not to be too aggressive because there are some untoward things you may not see right away.” He advised evaluating short- and long-term outcomes and being wary of devices that heat very deeply and rely on long-term outcomes, such as hair removal, acne improvement, scar improvement, and skin tightening – all of which require long intervals for assessment. As one of his “Ross Rules” states: “The deeper the heating and the less focused the heating, the less we can expect results.” Another Ross Rule calls for being skeptical about technologies without an immediate finding that can be “seen” on routine histology. “To me, the deeper the procedure, particularly if it’s not fractional, the confidence of my outcome is diminished,” he said. “The exception is any intervention that relies on selective photothermolysis.”

Using new technologies in practice

Dr. Ross also offered tips on how to properly incorporate newly approved technologies into your practice safely, including the use of visual endpoints. “That’s tough for technologies like laser liposuction or fractional technologies, where we rely more on ‘guidelines’ than endpoints,” he said. In addition, he recommended gradually increasing settings and using test areas to stall and/or hone techniques. “It’s exciting, but you’re like a test pilot. You want to be careful that you are doing things that are not likely to risk the patient. Try some off-the-face applications first. When you’re using a new technology, push a little harder with each patient so you can find a safe zone for that technology. You don’t have to get it all in one treatment session. Be conservative. Anticipate that you may be underassessing the immediate response.”

Above all, be careful. “Use your judgment more than laser company-prescribed settings,” he said. “Most companies have the go-by settings on the low side for patient protection, but sometimes efficacy suffers. Use cautiously on friends and family. If you treat a spouse or a friend and things don’t go perfectly, that’s always a recipe for a problem.”

Dr. Ross reported having received financial grants and research grants from Candela, Cutera, Lumenis, and Lutronic; consulting fees from Palomar; and honoraria from Cynosure, Cutera, and Lumenis. He has also received research funding from Venous Concepts, Pulsed Biosciences, and Cynosure.

[email protected]

A healthy dose of skepticism is reasonable when evaluating new technologies to potentially use in your practice, but being overly critical can backfire, according to E. Victor Ross, MD.

During a virtual course on laser and aesthetic skin therapy, he noted that dermatologists may be evaluating new technologies in roles as an investigator or provider, or as a provider who buys the equipment outright, without any direct compensation from industry. “If you’re doing investigative work, you’re already in a conflicted situation because you’re trying to serve two masters,” said Dr. Ross, who directs the Scripps Clinic Laser and Cosmetic Dermatology Center in San Diego. “You’re trying to advance science and to make sure your reputation is intact and maybe even enhanced, but you’re also kind of at the whim of industry, because they have a goal. Sometimes the goals are similar. Your goal is to advance the technology and advance patient care, but they have a goal of selling equipment. Those goals should be compatible, and they should be in the same pathway; they should be parallel.”

Being too critical as an investigator/researcher of new technologies can hinder further interactions with industry. “Sometimes your criticism can be premature, and small changes in the technology and/or waiting for results can validate the technology,” he said. “Maybe it’s a skin-tightening technology, or maybe there’s something you don’t like about it; you have a prototype and you say: ‘This is not so great,’ but these are studies that take a long time to evaluate, like hair removal. Generally, if you’re a big critic, after a while, nobody wants to hear it. So, you can’t be overly critical. I think you can be skeptical, but not overly critical.”

On the other hand, Dr. Ross continued, if you cheerlead for the device industry, your reputation may be sold to the highest bidder. “You may compromise your ability to be trusted in future work or presentations. I’ve regretted some things I said many years ago, not because I was being dishonest but because I really wasn’t as skeptical as I should have been about the types of results I was getting. You do tend to get on a bandwagon; you want everything to be positive,” he said, adding: “The other thing that can happen is, if things don’t work out with other buyers, they’re going to say, ‘I can’t get the same results.’ If somebody can’t replicate what you’re doing, it’s going to put your reputation on the line to some degree. So, you have to be very careful.”

Before agreeing to evaluate a new technology as an investigator or in your own practice, Dr. Ross recommended asking yourself if the intervention makes sense on a gross or microanatomic level. “There should be a physical basis for how it works, and ideally there should be some histology that backs it up,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Where is the data to support the outcomes? If it is your own data, how skeptical have you been in its acquisition and assessment?”

When evaluating a new technology, Dr. Ross recommended starting with test spots and low settings. “It behooves you not to be too aggressive because there are some untoward things you may not see right away.” He advised evaluating short- and long-term outcomes and being wary of devices that heat very deeply and rely on long-term outcomes, such as hair removal, acne improvement, scar improvement, and skin tightening – all of which require long intervals for assessment. As one of his “Ross Rules” states: “The deeper the heating and the less focused the heating, the less we can expect results.” Another Ross Rule calls for being skeptical about technologies without an immediate finding that can be “seen” on routine histology. “To me, the deeper the procedure, particularly if it’s not fractional, the confidence of my outcome is diminished,” he said. “The exception is any intervention that relies on selective photothermolysis.”

Using new technologies in practice

Dr. Ross also offered tips on how to properly incorporate newly approved technologies into your practice safely, including the use of visual endpoints. “That’s tough for technologies like laser liposuction or fractional technologies, where we rely more on ‘guidelines’ than endpoints,” he said. In addition, he recommended gradually increasing settings and using test areas to stall and/or hone techniques. “It’s exciting, but you’re like a test pilot. You want to be careful that you are doing things that are not likely to risk the patient. Try some off-the-face applications first. When you’re using a new technology, push a little harder with each patient so you can find a safe zone for that technology. You don’t have to get it all in one treatment session. Be conservative. Anticipate that you may be underassessing the immediate response.”

Above all, be careful. “Use your judgment more than laser company-prescribed settings,” he said. “Most companies have the go-by settings on the low side for patient protection, but sometimes efficacy suffers. Use cautiously on friends and family. If you treat a spouse or a friend and things don’t go perfectly, that’s always a recipe for a problem.”

Dr. Ross reported having received financial grants and research grants from Candela, Cutera, Lumenis, and Lutronic; consulting fees from Palomar; and honoraria from Cynosure, Cutera, and Lumenis. He has also received research funding from Venous Concepts, Pulsed Biosciences, and Cynosure.

[email protected]

A healthy dose of skepticism is reasonable when evaluating new technologies to potentially use in your practice, but being overly critical can backfire, according to E. Victor Ross, MD.

During a virtual course on laser and aesthetic skin therapy, he noted that dermatologists may be evaluating new technologies in roles as an investigator or provider, or as a provider who buys the equipment outright, without any direct compensation from industry. “If you’re doing investigative work, you’re already in a conflicted situation because you’re trying to serve two masters,” said Dr. Ross, who directs the Scripps Clinic Laser and Cosmetic Dermatology Center in San Diego. “You’re trying to advance science and to make sure your reputation is intact and maybe even enhanced, but you’re also kind of at the whim of industry, because they have a goal. Sometimes the goals are similar. Your goal is to advance the technology and advance patient care, but they have a goal of selling equipment. Those goals should be compatible, and they should be in the same pathway; they should be parallel.”

Being too critical as an investigator/researcher of new technologies can hinder further interactions with industry. “Sometimes your criticism can be premature, and small changes in the technology and/or waiting for results can validate the technology,” he said. “Maybe it’s a skin-tightening technology, or maybe there’s something you don’t like about it; you have a prototype and you say: ‘This is not so great,’ but these are studies that take a long time to evaluate, like hair removal. Generally, if you’re a big critic, after a while, nobody wants to hear it. So, you can’t be overly critical. I think you can be skeptical, but not overly critical.”

On the other hand, Dr. Ross continued, if you cheerlead for the device industry, your reputation may be sold to the highest bidder. “You may compromise your ability to be trusted in future work or presentations. I’ve regretted some things I said many years ago, not because I was being dishonest but because I really wasn’t as skeptical as I should have been about the types of results I was getting. You do tend to get on a bandwagon; you want everything to be positive,” he said, adding: “The other thing that can happen is, if things don’t work out with other buyers, they’re going to say, ‘I can’t get the same results.’ If somebody can’t replicate what you’re doing, it’s going to put your reputation on the line to some degree. So, you have to be very careful.”

Before agreeing to evaluate a new technology as an investigator or in your own practice, Dr. Ross recommended asking yourself if the intervention makes sense on a gross or microanatomic level. “There should be a physical basis for how it works, and ideally there should be some histology that backs it up,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Where is the data to support the outcomes? If it is your own data, how skeptical have you been in its acquisition and assessment?”

When evaluating a new technology, Dr. Ross recommended starting with test spots and low settings. “It behooves you not to be too aggressive because there are some untoward things you may not see right away.” He advised evaluating short- and long-term outcomes and being wary of devices that heat very deeply and rely on long-term outcomes, such as hair removal, acne improvement, scar improvement, and skin tightening – all of which require long intervals for assessment. As one of his “Ross Rules” states: “The deeper the heating and the less focused the heating, the less we can expect results.” Another Ross Rule calls for being skeptical about technologies without an immediate finding that can be “seen” on routine histology. “To me, the deeper the procedure, particularly if it’s not fractional, the confidence of my outcome is diminished,” he said. “The exception is any intervention that relies on selective photothermolysis.”

Using new technologies in practice

Dr. Ross also offered tips on how to properly incorporate newly approved technologies into your practice safely, including the use of visual endpoints. “That’s tough for technologies like laser liposuction or fractional technologies, where we rely more on ‘guidelines’ than endpoints,” he said. In addition, he recommended gradually increasing settings and using test areas to stall and/or hone techniques. “It’s exciting, but you’re like a test pilot. You want to be careful that you are doing things that are not likely to risk the patient. Try some off-the-face applications first. When you’re using a new technology, push a little harder with each patient so you can find a safe zone for that technology. You don’t have to get it all in one treatment session. Be conservative. Anticipate that you may be underassessing the immediate response.”

Above all, be careful. “Use your judgment more than laser company-prescribed settings,” he said. “Most companies have the go-by settings on the low side for patient protection, but sometimes efficacy suffers. Use cautiously on friends and family. If you treat a spouse or a friend and things don’t go perfectly, that’s always a recipe for a problem.”

Dr. Ross reported having received financial grants and research grants from Candela, Cutera, Lumenis, and Lutronic; consulting fees from Palomar; and honoraria from Cynosure, Cutera, and Lumenis. He has also received research funding from Venous Concepts, Pulsed Biosciences, and Cynosure.

[email protected]

When a patient with cancer develops venous thromboembolism despite anticoagulation, how to help them comes down to clinical judgment, according to hematologist Neil Zakai, MD, associate professor at the University of Vermont, Burlington.

“Unfortunately,” when it comes to “anticoagulation failure, we are entering an evidence free-zone,” with no large trials to guide management and only a few guiding principles, he said during his presentation at the 2020 Update in Nonneoplastic Hematology virtual conference.

The first thing is to check if there was an inciting incident, such as medical noncompliance, an infection, or an interruption of anticoagulation. Dr. Zakai said he’s even had cancer patients develop heparin-induced thrombocytopenia when switched to enoxaparin from a direct oral anticoagulants (DOAC) for a procedure.

Once the underlying problem is addressed, patients may be able to continue with their original anticoagulant.

However, cancer progression is the main reason anticoagulation fails. “In general, it is very difficult to control cancer thrombosis if you can’t control cancer progression,” Dr. Zakai said.

In those cases, he steps up anticoagulation. Prophylactic dosing is increased to full treatment dosing, and patients on a DOAC are generally switched to a low molecular weight heparin (LMWH).

If patients are already on LMWH once daily, they will be bumped up to twice daily dosing; for instance, enoxaparin 1 mg/kg b.i.d. instead of 1.5 mg/kg q.d. Dr. Zakai said he’s gone as high at 2 or even 2.5 mg/kg to control thrombosis, without excessive bleeding.

In general, anticoagulation for thrombosis prophylaxis continues as long as the cancer is active, and certainly while patients are on hormonal treatments such as tamoxifen, which increases the risk.

Dr. Zakai stressed that both thrombosis and bleeding risk change for cancer patients over time, and treatment needs to keep up.

“I continuously assess the risk and benefit of anticoagulation. At certain times” such as during and for a few months after hospitalization, thrombosis risk increases; at other times, bleeding risk is higher. “You need to actively change your anticoagulation during those periods,” and tailor therapy based on transient risk factors. “People with cancer have peaks and troughs for their risk that we don’t take advantage of,” he said.

Dr. Zakai generally favors apixaban or enoxaparin for prophylaxis, carefully monitoring patients for bleeding and, for the DOAC, drug interactions with antiemetics, dexamethasone, and certain chemotherapy drugs.

He noted a recent trial that found a 59% reduction in venous thromboembolism risk in ambulatory cancer patients with apixaban 2.5 mg twice daily over 6 months, versus placebo, and a 6% absolute reduction, but at the cost of a twofold increase in bleeding risk, with an absolute 1.7% increase.

Dr. Zakai cautioned that patients in trials are selected for higher VTE and lower bleeding risks, so outcomes might “poorly reflect real world populations.” Dr. Zakai did not have any industry disclosures. The conference was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

[email protected]

When a patient with cancer develops venous thromboembolism despite anticoagulation, how to help them comes down to clinical judgment, according to hematologist Neil Zakai, MD, associate professor at the University of Vermont, Burlington.

“Unfortunately,” when it comes to “anticoagulation failure, we are entering an evidence free-zone,” with no large trials to guide management and only a few guiding principles, he said during his presentation at the 2020 Update in Nonneoplastic Hematology virtual conference.

The first thing is to check if there was an inciting incident, such as medical noncompliance, an infection, or an interruption of anticoagulation. Dr. Zakai said he’s even had cancer patients develop heparin-induced thrombocytopenia when switched to enoxaparin from a direct oral anticoagulants (DOAC) for a procedure.

Once the underlying problem is addressed, patients may be able to continue with their original anticoagulant.

However, cancer progression is the main reason anticoagulation fails. “In general, it is very difficult to control cancer thrombosis if you can’t control cancer progression,” Dr. Zakai said.

In those cases, he steps up anticoagulation. Prophylactic dosing is increased to full treatment dosing, and patients on a DOAC are generally switched to a low molecular weight heparin (LMWH).

If patients are already on LMWH once daily, they will be bumped up to twice daily dosing; for instance, enoxaparin 1 mg/kg b.i.d. instead of 1.5 mg/kg q.d. Dr. Zakai said he’s gone as high at 2 or even 2.5 mg/kg to control thrombosis, without excessive bleeding.

In general, anticoagulation for thrombosis prophylaxis continues as long as the cancer is active, and certainly while patients are on hormonal treatments such as tamoxifen, which increases the risk.

Dr. Zakai stressed that both thrombosis and bleeding risk change for cancer patients over time, and treatment needs to keep up.

“I continuously assess the risk and benefit of anticoagulation. At certain times” such as during and for a few months after hospitalization, thrombosis risk increases; at other times, bleeding risk is higher. “You need to actively change your anticoagulation during those periods,” and tailor therapy based on transient risk factors. “People with cancer have peaks and troughs for their risk that we don’t take advantage of,” he said.

Dr. Zakai generally favors apixaban or enoxaparin for prophylaxis, carefully monitoring patients for bleeding and, for the DOAC, drug interactions with antiemetics, dexamethasone, and certain chemotherapy drugs.

He noted a recent trial that found a 59% reduction in venous thromboembolism risk in ambulatory cancer patients with apixaban 2.5 mg twice daily over 6 months, versus placebo, and a 6% absolute reduction, but at the cost of a twofold increase in bleeding risk, with an absolute 1.7% increase.

Dr. Zakai cautioned that patients in trials are selected for higher VTE and lower bleeding risks, so outcomes might “poorly reflect real world populations.” Dr. Zakai did not have any industry disclosures. The conference was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

[email protected]

When a patient with cancer develops venous thromboembolism despite anticoagulation, how to help them comes down to clinical judgment, according to hematologist Neil Zakai, MD, associate professor at the University of Vermont, Burlington.

“Unfortunately,” when it comes to “anticoagulation failure, we are entering an evidence free-zone,” with no large trials to guide management and only a few guiding principles, he said during his presentation at the 2020 Update in Nonneoplastic Hematology virtual conference.

The first thing is to check if there was an inciting incident, such as medical noncompliance, an infection, or an interruption of anticoagulation. Dr. Zakai said he’s even had cancer patients develop heparin-induced thrombocytopenia when switched to enoxaparin from a direct oral anticoagulants (DOAC) for a procedure.

Once the underlying problem is addressed, patients may be able to continue with their original anticoagulant.

However, cancer progression is the main reason anticoagulation fails. “In general, it is very difficult to control cancer thrombosis if you can’t control cancer progression,” Dr. Zakai said.

In those cases, he steps up anticoagulation. Prophylactic dosing is increased to full treatment dosing, and patients on a DOAC are generally switched to a low molecular weight heparin (LMWH).

If patients are already on LMWH once daily, they will be bumped up to twice daily dosing; for instance, enoxaparin 1 mg/kg b.i.d. instead of 1.5 mg/kg q.d. Dr. Zakai said he’s gone as high at 2 or even 2.5 mg/kg to control thrombosis, without excessive bleeding.

In general, anticoagulation for thrombosis prophylaxis continues as long as the cancer is active, and certainly while patients are on hormonal treatments such as tamoxifen, which increases the risk.

Dr. Zakai stressed that both thrombosis and bleeding risk change for cancer patients over time, and treatment needs to keep up.

“I continuously assess the risk and benefit of anticoagulation. At certain times” such as during and for a few months after hospitalization, thrombosis risk increases; at other times, bleeding risk is higher. “You need to actively change your anticoagulation during those periods,” and tailor therapy based on transient risk factors. “People with cancer have peaks and troughs for their risk that we don’t take advantage of,” he said.

Dr. Zakai generally favors apixaban or enoxaparin for prophylaxis, carefully monitoring patients for bleeding and, for the DOAC, drug interactions with antiemetics, dexamethasone, and certain chemotherapy drugs.

He noted a recent trial that found a 59% reduction in venous thromboembolism risk in ambulatory cancer patients with apixaban 2.5 mg twice daily over 6 months, versus placebo, and a 6% absolute reduction, but at the cost of a twofold increase in bleeding risk, with an absolute 1.7% increase.

Dr. Zakai cautioned that patients in trials are selected for higher VTE and lower bleeding risks, so outcomes might “poorly reflect real world populations.” Dr. Zakai did not have any industry disclosures. The conference was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

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

[email protected]

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

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

[email protected]

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

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

[email protected]

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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