Evaluate, manage the stress response in susceptible individuals affected by COVID-19

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Steroid therapy should be explored for quarantined mental health patients

Psychological First Aid is an innovative program launched by the American Red Cross with the goal of addressing issues of concern such as those stemming from COVID-19–related stress. According to Red Cross mental health volunteer representative Deb Butman-Perkins, the program provides “a general overview of what does stress look like, how do we feel it, how do we recognize it in our bodies ... physical, emotional, spiritual, physiological, where does all that stress occur?”1

Dr. Faisal A. Islam

The program brings a spotlight to the interdisciplinary nature of the stress response, especially with respect to the importance of developing the necessary coping skills during an ongoing crisis. However, to effectively evaluate and manage the overall stress response for psychiatric patients during quarantine conditions, as well as those who are formally diagnosed with COVID-19, clinicians also will need to revisit what we’ve learned about the hypothalamic-pituitary-adrenal (HPA) axis.

We know that the stress response – which varies somewhat across the spectrum – is necessary to ensure homeostatic regulation. A feedback loop is initiated at the receptor level, involving a myriad of hormones and chemical signals that bring forth the body’s “flight-or-fight” response. Hormones such as epinephrine/norepinephrine and cortisol are secreted by the HPA axis in reaction to the stress response, resulting in a spike in heart rate, blood pressure, and transient hyperglycemia, respectively. In particular, hyperglycemia provides immediate energy to muscles during a perceived crisis.2

In addition, prolonged exposure to living in quarantine can lead to feelings of isolation and estrangement – and excessive anxiety. Combined, those conditions may exert an indelible effect on the HPA axis – leading to a warped pattern of cortisol secretion with respect to baseline.3 (It has been noted in the literature that serum cortisol plays a protective role in thwarting off the effects of PTSD development. Consistent with this line of thinking, military personnel have been preemptively treated with high-dose cortisol during acute exposure.)

Prolonged exposure to psychosocial stressors also increases the overall risk of developing medical comorbidities. Patients who adopt maladaptive responses to traumatic events, for example, may experience dysregulation in eating behaviors and/or disordered sleep.4

In light of those realities, clinicians should explore the role of steroid therapy as a means of treating mental health patients experiencing psychological stress formation tied to ongoing quarantine conditions.
 

Challenges of neuroendocrine medications for COVID-19

COVID-19, caused by exposure to SARS-CoV-2, adeptly leverages the ACE2 receptor of the lungs as an entry point to evade the host’s defenses. It should be noted that the ACE2 protein is expressed on the cells of multiple organs of the body, including the adrenals, which are largely responsible for coordinating the stress response of the HPA axis.

Dr. Mohammed S. Islam

Postmortem analysis from severe acute respiratory syndrome (SARS-CoV is also from the Coronaviridae family) patients indicates the presence of necrotic adrenal cells, further solidifying the association of the HPA axis to the COVID-19 disease state and pathophysiological course.5 Molecular mimicry of the adrenocorticotropic hormone allows SARS-CoV the ability to infiltrate the host’s defenses, in particular, the ability to mount a clinically apt cortisol stress response (e.g., hypocortisolism).As for those who survived the 2003 SARS outbreak, less than half of the patients have been observed to develop symptoms of frank hypocortisolism within a few months after exposure.

The World Health Organization recently endorsed the use of steroid therapy for critically ill COVID-19 patients, and an ongoing clinical trial is evaluating the safety and efficacy parameters of corticosteroids in COVID-19–exposed patients.

In addition, there is reason to believe that application of prophylactic steroids might affect the overall clinical course of COVID-19, thereby reducing mortality and morbidity rates in patients with severe presentation, such as septic shock. The rationale for this line of thought is based on the ability of glucocorticoids to suppress an ensuing cytokine storm by the virus in question.5,6 In clinical practice, steroids have been used to treat a host of viral diseases, including influenza, respiratory syncytial virus, and Middle East respiratory syndrome coronavirus.

Aside from the selective use of corticosteroids, the medication regimen may incorporate ACE inhibitors and/or angiotensin receptor blockers (ARBs) because of COVID-19’s ability to activate the renin-angiotensin-aldosterone system with respect to the physiological stress response.

The interplay of the HPA axis with the sympathoadrenal system is responsible for adaptive behaviors in the individual. Disrupted feedback loops from prolonged activation are associated with numerous stress-based conditions in mental illness, namely, PTSD, anxiety, and mood disorders. We are concerned about frontline health care workers, who are particularly prone to chronic stress and burnout because of the cumbersome patient load and equipment shortage that have characterized the coronavirus crisis.

Timely administration of corticosteroids on a case-by-case basis would keep the cytokines at bay by precluding their undue activation of the HPA axis and corresponding cascade stress response. Steroids are also known to restore disrupted feedback loops at the level of the immune cells. However, because of conflicting reports concerning viral clearance in some SARS and COVID-19 studies, treatment with steroids may be limited to select patient populations with the necessary dose adjustments. Ongoing clinical trials will further elucidate upon the applicability of steroids as well as the role of other neuroendocrine agents, such as ACE inhibitors or ARBs, in the treatment of COVID-19.
 

 

 

Behavioral manifestations and psychosocial health

As far as the stress response is concerned, an analysis performed by researchers in China after the COVID-19 outbreak found gender disparities in symptom expression. In the study (n = 1,210) the researchers found in female citizens a greater frequency of behavioral manifestations, including acute stress reaction, and symptoms of anxiety and mood disorders – namely, depression.7 Patient perception and awareness of the perils of coronavirus typically varied across the spectrum; some individuals reportedly undermined and devalued their risk of contracting COVID-19 – these patients may benefit from therapeutic modalities, such as cognitive-behavioral therapy (CBT), as a means of challenging their firmly entrenched cognitive distortions. CBT is an effective tool in addressing maladaptive coping responses, because these strategies tend to correspond with poor prognosis with respect to overall mental health. Aside from CBT, the clinician may advise other behavioral techniques, such as relaxation training, with the aim of controlling the symptoms of mood and anxiety disorders.

Dr. Zia Choudhry

We often take for granted general pandemic safety precautions, such as maintaining physical distancing coupled with engaging in regular hand hygiene and wearing masks, but these actions also are known to alleviate mental anguish. Access to accurate and easy-to-consume health information regarding COVID-19 is also associated with psychological well-being during the quarantine.8

An intriguing “phenomenon” has emerged in the form of “panic buying.”However, researchers reported in the peer-reviewed journal Nature Human Behaviour that this pattern of behaviors is not typical for those under distress and represents an overstated misnomer of sorts. According to Jay J. Van Bavel, PhD, and associates, prevailing reports from news outlets have skewed the features of a panic. “News stories that employ the language of panic often create the very phenomena that they purport to condemn,” Dr. Van Bavel and associates wrote. “They can foster the very individualism and competitiveness that turn sensible preparations into dysfunctional stockpiling and undermine the sense of collective purpose which facilitates people supporting one another during an emergency.”9

The researchers proceeded to highlight the scope of effective crisis leadership with respect to establishing a sense of communal “self-efficacy and hope.” The influence of organized leadership serves to solidify the structure of the community as a whole, allowing group members the opportunity to address the stressors of interest. Such leadership may mitigate the stress response by fostering a necessary, healthy set for stress management.



Strategies aimed at supporting mental health

Coping and stress management strategies may include the process of building virtual networks (e.g., social media platforms) because physical distancing may contribute toward further isolation and social estrangement. However, it should be noted that ideally social media consumption should be centered upon interactive enrichment activities that provide a suitable substitute for the absence of physical support systems. The goal is to facilitate meaningful relationships and enduring communications that produce healthy and resilient mindsets.

In particular, individuals who possess adaptive mindsets with a realistic view of ongoing psychosocial stressors, be it from the impact of the pandemic or other influential events, are more likely to benefit when moving forward with life. In other words, the individual in question leverages these experiences as a means of “stress-related growth,” thereby enhancing the overall quality of relationships. Tentative studies in stress management have yielded promising support for interventions that aim to modulate mindsets (as a function of the stress response) by proper appraisal of the stress stimuli, according to Dr. Van Bavel and associates.
 

 

 

Employing assessment scales

To mitigate the stress response, clinicians need to use the relevant stress scales for assessing the full impact of distress brought on by COVID-19 and optimizing therapeutic modalities for those who need them most. Again, the stress response would vary, depending on the patient, and may include paranoia, xenophobia, compulsive ritualistic behavior, as well as full-fledged symptoms of acute stress disorder/PTSD.Steven Taylor, PhD, RPsych, and associates, part of a research team funded by the Canadian Institutes of Health Research and the University of Regina (Sask.), formulated their proprietary COVID Stress Scales (CSS) based on 36 items pertaining to individual anxiety and/or stress responses.10

As general purpose pandemic scales, the assessment tools will be transferable to similar outbreaks, and have been examined for validity and reliability. Additional validation scales include the Patient Health Questionnaire–4 for anxiety and depression, the Short Health Anxiety Inventory for anxiety (irrespective of physical condition), and the Marlowe-Crowne Social Desirability Scale–Short Form for psychological well-being based on the presence (or the lack thereof) of desirable characteristics.10 As a composite scale and predictive tool (especially with respect to future pandemics), the CSS allows clinicians a means of identifying the people who are most compliant with safety procedures, social distancing, hygiene expectations, and vaccine protocols – when applicable – reported Dr. Taylor and associates.
 

Moving forward: The next step in COVID-19 preparedness

As clinicians continue to develop guidelines that are befitting of COVID-19’s “new normal,” a holistic psychosocial framework will need to integrate the various psychometrics gathered from assessment scales, as well as understanding trauma, especially with respect to the HPA axis.

For starters, there is a certain element of “anticipatory anxiety” for those experiencing distress from COVID-19. A highly uncertain future with no immediate cure in the future, isolation and social estrangement, as well as financial setbacks, compound the situation. Moreover, the DSM fails to acknowledge other sources of traumatic experiences that are systemic in nature, such as discriminatory practices, injustice, and/or persecution.

It has also been noted that some distressed individuals experience a hypervigilant state that is comparable with PTSD.11 There may be a push to incorporate machine learning and other modalities to better identify those at risk (for example, health care professionals who perform their duties with limited resources, thereby inducing sleep dysregulation, anxiety, and hopelessness) for mental health deterioration. Interventions may need to be coordinated in a timely manner to disrupt the progression of acute stress disorder to PTSD. Peer support programs and resiliency training – successful therapeutic approaches for PTSD – may prove to have considerable utility for mitigating the overall stress response of COVID-19.12

References

1. “Red Cross offering online course to manage crisis-related stress.” ABC 6 News. kaaltv.com, 2020 Aug 29.

2. Islam FA, Choudhry C. J Psychiatry Psychiatric Disord 2017;1(5): 290-3.

3. Faravelli C et al. World J Psychiatry. 2012 Feb 22;2(1):13-25.

4. Carmassi C et al. Psychiatry Res. 2015 Jan 30;225(1-2):64-9.

5. Pal R. Endocrine. 2020 Apr 28. doi: 10.1007/s12020-020-02325-1.

6. Steenblock C et al. Mol Psychiatry. 2020 May. doi: 10.1038/s41380-020-0758-9.

7. Wang C et al. Int J Environ Res Public Health. 2020 Jan;17(5):1729.

8. Ho CS et al. Ann Acad Med Singap. 2020 Mar 16;49(3):155-60.

9. Van Bavel JJ et al. Nat Hum Behav. 2020 Apr 30. doi: 10.1038/s41562-020-0884-z.

10. Taylor S et al. J Anxiety Disord. 2020 May 4;72:102232.

11. Horesh D, Brown AD. Psychol Trauma. 2020 May;12(4):331-5.

12. Clark H et al. National Health Library and Knowledge Service/Evidence Team. Summary of Evidence: COVID-19, 2020 May 22. Version 2.0.

Dr. Faisal A. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Mohammed S. Islam is a research physician and extern at Interfaith Medical Center, New York. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. Dr. Jolayemi is an attending psychiatrist at Interfaith Medical Center. No disclosures were reported.

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Steroid therapy should be explored for quarantined mental health patients

Steroid therapy should be explored for quarantined mental health patients

Psychological First Aid is an innovative program launched by the American Red Cross with the goal of addressing issues of concern such as those stemming from COVID-19–related stress. According to Red Cross mental health volunteer representative Deb Butman-Perkins, the program provides “a general overview of what does stress look like, how do we feel it, how do we recognize it in our bodies ... physical, emotional, spiritual, physiological, where does all that stress occur?”1

Dr. Faisal A. Islam

The program brings a spotlight to the interdisciplinary nature of the stress response, especially with respect to the importance of developing the necessary coping skills during an ongoing crisis. However, to effectively evaluate and manage the overall stress response for psychiatric patients during quarantine conditions, as well as those who are formally diagnosed with COVID-19, clinicians also will need to revisit what we’ve learned about the hypothalamic-pituitary-adrenal (HPA) axis.

We know that the stress response – which varies somewhat across the spectrum – is necessary to ensure homeostatic regulation. A feedback loop is initiated at the receptor level, involving a myriad of hormones and chemical signals that bring forth the body’s “flight-or-fight” response. Hormones such as epinephrine/norepinephrine and cortisol are secreted by the HPA axis in reaction to the stress response, resulting in a spike in heart rate, blood pressure, and transient hyperglycemia, respectively. In particular, hyperglycemia provides immediate energy to muscles during a perceived crisis.2

In addition, prolonged exposure to living in quarantine can lead to feelings of isolation and estrangement – and excessive anxiety. Combined, those conditions may exert an indelible effect on the HPA axis – leading to a warped pattern of cortisol secretion with respect to baseline.3 (It has been noted in the literature that serum cortisol plays a protective role in thwarting off the effects of PTSD development. Consistent with this line of thinking, military personnel have been preemptively treated with high-dose cortisol during acute exposure.)

Prolonged exposure to psychosocial stressors also increases the overall risk of developing medical comorbidities. Patients who adopt maladaptive responses to traumatic events, for example, may experience dysregulation in eating behaviors and/or disordered sleep.4

In light of those realities, clinicians should explore the role of steroid therapy as a means of treating mental health patients experiencing psychological stress formation tied to ongoing quarantine conditions.
 

Challenges of neuroendocrine medications for COVID-19

COVID-19, caused by exposure to SARS-CoV-2, adeptly leverages the ACE2 receptor of the lungs as an entry point to evade the host’s defenses. It should be noted that the ACE2 protein is expressed on the cells of multiple organs of the body, including the adrenals, which are largely responsible for coordinating the stress response of the HPA axis.

Dr. Mohammed S. Islam

Postmortem analysis from severe acute respiratory syndrome (SARS-CoV is also from the Coronaviridae family) patients indicates the presence of necrotic adrenal cells, further solidifying the association of the HPA axis to the COVID-19 disease state and pathophysiological course.5 Molecular mimicry of the adrenocorticotropic hormone allows SARS-CoV the ability to infiltrate the host’s defenses, in particular, the ability to mount a clinically apt cortisol stress response (e.g., hypocortisolism).As for those who survived the 2003 SARS outbreak, less than half of the patients have been observed to develop symptoms of frank hypocortisolism within a few months after exposure.

The World Health Organization recently endorsed the use of steroid therapy for critically ill COVID-19 patients, and an ongoing clinical trial is evaluating the safety and efficacy parameters of corticosteroids in COVID-19–exposed patients.

In addition, there is reason to believe that application of prophylactic steroids might affect the overall clinical course of COVID-19, thereby reducing mortality and morbidity rates in patients with severe presentation, such as septic shock. The rationale for this line of thought is based on the ability of glucocorticoids to suppress an ensuing cytokine storm by the virus in question.5,6 In clinical practice, steroids have been used to treat a host of viral diseases, including influenza, respiratory syncytial virus, and Middle East respiratory syndrome coronavirus.

Aside from the selective use of corticosteroids, the medication regimen may incorporate ACE inhibitors and/or angiotensin receptor blockers (ARBs) because of COVID-19’s ability to activate the renin-angiotensin-aldosterone system with respect to the physiological stress response.

The interplay of the HPA axis with the sympathoadrenal system is responsible for adaptive behaviors in the individual. Disrupted feedback loops from prolonged activation are associated with numerous stress-based conditions in mental illness, namely, PTSD, anxiety, and mood disorders. We are concerned about frontline health care workers, who are particularly prone to chronic stress and burnout because of the cumbersome patient load and equipment shortage that have characterized the coronavirus crisis.

Timely administration of corticosteroids on a case-by-case basis would keep the cytokines at bay by precluding their undue activation of the HPA axis and corresponding cascade stress response. Steroids are also known to restore disrupted feedback loops at the level of the immune cells. However, because of conflicting reports concerning viral clearance in some SARS and COVID-19 studies, treatment with steroids may be limited to select patient populations with the necessary dose adjustments. Ongoing clinical trials will further elucidate upon the applicability of steroids as well as the role of other neuroendocrine agents, such as ACE inhibitors or ARBs, in the treatment of COVID-19.
 

 

 

Behavioral manifestations and psychosocial health

As far as the stress response is concerned, an analysis performed by researchers in China after the COVID-19 outbreak found gender disparities in symptom expression. In the study (n = 1,210) the researchers found in female citizens a greater frequency of behavioral manifestations, including acute stress reaction, and symptoms of anxiety and mood disorders – namely, depression.7 Patient perception and awareness of the perils of coronavirus typically varied across the spectrum; some individuals reportedly undermined and devalued their risk of contracting COVID-19 – these patients may benefit from therapeutic modalities, such as cognitive-behavioral therapy (CBT), as a means of challenging their firmly entrenched cognitive distortions. CBT is an effective tool in addressing maladaptive coping responses, because these strategies tend to correspond with poor prognosis with respect to overall mental health. Aside from CBT, the clinician may advise other behavioral techniques, such as relaxation training, with the aim of controlling the symptoms of mood and anxiety disorders.

Dr. Zia Choudhry

We often take for granted general pandemic safety precautions, such as maintaining physical distancing coupled with engaging in regular hand hygiene and wearing masks, but these actions also are known to alleviate mental anguish. Access to accurate and easy-to-consume health information regarding COVID-19 is also associated with psychological well-being during the quarantine.8

An intriguing “phenomenon” has emerged in the form of “panic buying.”However, researchers reported in the peer-reviewed journal Nature Human Behaviour that this pattern of behaviors is not typical for those under distress and represents an overstated misnomer of sorts. According to Jay J. Van Bavel, PhD, and associates, prevailing reports from news outlets have skewed the features of a panic. “News stories that employ the language of panic often create the very phenomena that they purport to condemn,” Dr. Van Bavel and associates wrote. “They can foster the very individualism and competitiveness that turn sensible preparations into dysfunctional stockpiling and undermine the sense of collective purpose which facilitates people supporting one another during an emergency.”9

The researchers proceeded to highlight the scope of effective crisis leadership with respect to establishing a sense of communal “self-efficacy and hope.” The influence of organized leadership serves to solidify the structure of the community as a whole, allowing group members the opportunity to address the stressors of interest. Such leadership may mitigate the stress response by fostering a necessary, healthy set for stress management.



Strategies aimed at supporting mental health

Coping and stress management strategies may include the process of building virtual networks (e.g., social media platforms) because physical distancing may contribute toward further isolation and social estrangement. However, it should be noted that ideally social media consumption should be centered upon interactive enrichment activities that provide a suitable substitute for the absence of physical support systems. The goal is to facilitate meaningful relationships and enduring communications that produce healthy and resilient mindsets.

In particular, individuals who possess adaptive mindsets with a realistic view of ongoing psychosocial stressors, be it from the impact of the pandemic or other influential events, are more likely to benefit when moving forward with life. In other words, the individual in question leverages these experiences as a means of “stress-related growth,” thereby enhancing the overall quality of relationships. Tentative studies in stress management have yielded promising support for interventions that aim to modulate mindsets (as a function of the stress response) by proper appraisal of the stress stimuli, according to Dr. Van Bavel and associates.
 

 

 

Employing assessment scales

To mitigate the stress response, clinicians need to use the relevant stress scales for assessing the full impact of distress brought on by COVID-19 and optimizing therapeutic modalities for those who need them most. Again, the stress response would vary, depending on the patient, and may include paranoia, xenophobia, compulsive ritualistic behavior, as well as full-fledged symptoms of acute stress disorder/PTSD.Steven Taylor, PhD, RPsych, and associates, part of a research team funded by the Canadian Institutes of Health Research and the University of Regina (Sask.), formulated their proprietary COVID Stress Scales (CSS) based on 36 items pertaining to individual anxiety and/or stress responses.10

As general purpose pandemic scales, the assessment tools will be transferable to similar outbreaks, and have been examined for validity and reliability. Additional validation scales include the Patient Health Questionnaire–4 for anxiety and depression, the Short Health Anxiety Inventory for anxiety (irrespective of physical condition), and the Marlowe-Crowne Social Desirability Scale–Short Form for psychological well-being based on the presence (or the lack thereof) of desirable characteristics.10 As a composite scale and predictive tool (especially with respect to future pandemics), the CSS allows clinicians a means of identifying the people who are most compliant with safety procedures, social distancing, hygiene expectations, and vaccine protocols – when applicable – reported Dr. Taylor and associates.
 

Moving forward: The next step in COVID-19 preparedness

As clinicians continue to develop guidelines that are befitting of COVID-19’s “new normal,” a holistic psychosocial framework will need to integrate the various psychometrics gathered from assessment scales, as well as understanding trauma, especially with respect to the HPA axis.

For starters, there is a certain element of “anticipatory anxiety” for those experiencing distress from COVID-19. A highly uncertain future with no immediate cure in the future, isolation and social estrangement, as well as financial setbacks, compound the situation. Moreover, the DSM fails to acknowledge other sources of traumatic experiences that are systemic in nature, such as discriminatory practices, injustice, and/or persecution.

It has also been noted that some distressed individuals experience a hypervigilant state that is comparable with PTSD.11 There may be a push to incorporate machine learning and other modalities to better identify those at risk (for example, health care professionals who perform their duties with limited resources, thereby inducing sleep dysregulation, anxiety, and hopelessness) for mental health deterioration. Interventions may need to be coordinated in a timely manner to disrupt the progression of acute stress disorder to PTSD. Peer support programs and resiliency training – successful therapeutic approaches for PTSD – may prove to have considerable utility for mitigating the overall stress response of COVID-19.12

References

1. “Red Cross offering online course to manage crisis-related stress.” ABC 6 News. kaaltv.com, 2020 Aug 29.

2. Islam FA, Choudhry C. J Psychiatry Psychiatric Disord 2017;1(5): 290-3.

3. Faravelli C et al. World J Psychiatry. 2012 Feb 22;2(1):13-25.

4. Carmassi C et al. Psychiatry Res. 2015 Jan 30;225(1-2):64-9.

5. Pal R. Endocrine. 2020 Apr 28. doi: 10.1007/s12020-020-02325-1.

6. Steenblock C et al. Mol Psychiatry. 2020 May. doi: 10.1038/s41380-020-0758-9.

7. Wang C et al. Int J Environ Res Public Health. 2020 Jan;17(5):1729.

8. Ho CS et al. Ann Acad Med Singap. 2020 Mar 16;49(3):155-60.

9. Van Bavel JJ et al. Nat Hum Behav. 2020 Apr 30. doi: 10.1038/s41562-020-0884-z.

10. Taylor S et al. J Anxiety Disord. 2020 May 4;72:102232.

11. Horesh D, Brown AD. Psychol Trauma. 2020 May;12(4):331-5.

12. Clark H et al. National Health Library and Knowledge Service/Evidence Team. Summary of Evidence: COVID-19, 2020 May 22. Version 2.0.

Dr. Faisal A. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Mohammed S. Islam is a research physician and extern at Interfaith Medical Center, New York. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. Dr. Jolayemi is an attending psychiatrist at Interfaith Medical Center. No disclosures were reported.

Psychological First Aid is an innovative program launched by the American Red Cross with the goal of addressing issues of concern such as those stemming from COVID-19–related stress. According to Red Cross mental health volunteer representative Deb Butman-Perkins, the program provides “a general overview of what does stress look like, how do we feel it, how do we recognize it in our bodies ... physical, emotional, spiritual, physiological, where does all that stress occur?”1

Dr. Faisal A. Islam

The program brings a spotlight to the interdisciplinary nature of the stress response, especially with respect to the importance of developing the necessary coping skills during an ongoing crisis. However, to effectively evaluate and manage the overall stress response for psychiatric patients during quarantine conditions, as well as those who are formally diagnosed with COVID-19, clinicians also will need to revisit what we’ve learned about the hypothalamic-pituitary-adrenal (HPA) axis.

We know that the stress response – which varies somewhat across the spectrum – is necessary to ensure homeostatic regulation. A feedback loop is initiated at the receptor level, involving a myriad of hormones and chemical signals that bring forth the body’s “flight-or-fight” response. Hormones such as epinephrine/norepinephrine and cortisol are secreted by the HPA axis in reaction to the stress response, resulting in a spike in heart rate, blood pressure, and transient hyperglycemia, respectively. In particular, hyperglycemia provides immediate energy to muscles during a perceived crisis.2

In addition, prolonged exposure to living in quarantine can lead to feelings of isolation and estrangement – and excessive anxiety. Combined, those conditions may exert an indelible effect on the HPA axis – leading to a warped pattern of cortisol secretion with respect to baseline.3 (It has been noted in the literature that serum cortisol plays a protective role in thwarting off the effects of PTSD development. Consistent with this line of thinking, military personnel have been preemptively treated with high-dose cortisol during acute exposure.)

Prolonged exposure to psychosocial stressors also increases the overall risk of developing medical comorbidities. Patients who adopt maladaptive responses to traumatic events, for example, may experience dysregulation in eating behaviors and/or disordered sleep.4

In light of those realities, clinicians should explore the role of steroid therapy as a means of treating mental health patients experiencing psychological stress formation tied to ongoing quarantine conditions.
 

Challenges of neuroendocrine medications for COVID-19

COVID-19, caused by exposure to SARS-CoV-2, adeptly leverages the ACE2 receptor of the lungs as an entry point to evade the host’s defenses. It should be noted that the ACE2 protein is expressed on the cells of multiple organs of the body, including the adrenals, which are largely responsible for coordinating the stress response of the HPA axis.

Dr. Mohammed S. Islam

Postmortem analysis from severe acute respiratory syndrome (SARS-CoV is also from the Coronaviridae family) patients indicates the presence of necrotic adrenal cells, further solidifying the association of the HPA axis to the COVID-19 disease state and pathophysiological course.5 Molecular mimicry of the adrenocorticotropic hormone allows SARS-CoV the ability to infiltrate the host’s defenses, in particular, the ability to mount a clinically apt cortisol stress response (e.g., hypocortisolism).As for those who survived the 2003 SARS outbreak, less than half of the patients have been observed to develop symptoms of frank hypocortisolism within a few months after exposure.

The World Health Organization recently endorsed the use of steroid therapy for critically ill COVID-19 patients, and an ongoing clinical trial is evaluating the safety and efficacy parameters of corticosteroids in COVID-19–exposed patients.

In addition, there is reason to believe that application of prophylactic steroids might affect the overall clinical course of COVID-19, thereby reducing mortality and morbidity rates in patients with severe presentation, such as septic shock. The rationale for this line of thought is based on the ability of glucocorticoids to suppress an ensuing cytokine storm by the virus in question.5,6 In clinical practice, steroids have been used to treat a host of viral diseases, including influenza, respiratory syncytial virus, and Middle East respiratory syndrome coronavirus.

Aside from the selective use of corticosteroids, the medication regimen may incorporate ACE inhibitors and/or angiotensin receptor blockers (ARBs) because of COVID-19’s ability to activate the renin-angiotensin-aldosterone system with respect to the physiological stress response.

The interplay of the HPA axis with the sympathoadrenal system is responsible for adaptive behaviors in the individual. Disrupted feedback loops from prolonged activation are associated with numerous stress-based conditions in mental illness, namely, PTSD, anxiety, and mood disorders. We are concerned about frontline health care workers, who are particularly prone to chronic stress and burnout because of the cumbersome patient load and equipment shortage that have characterized the coronavirus crisis.

Timely administration of corticosteroids on a case-by-case basis would keep the cytokines at bay by precluding their undue activation of the HPA axis and corresponding cascade stress response. Steroids are also known to restore disrupted feedback loops at the level of the immune cells. However, because of conflicting reports concerning viral clearance in some SARS and COVID-19 studies, treatment with steroids may be limited to select patient populations with the necessary dose adjustments. Ongoing clinical trials will further elucidate upon the applicability of steroids as well as the role of other neuroendocrine agents, such as ACE inhibitors or ARBs, in the treatment of COVID-19.
 

 

 

Behavioral manifestations and psychosocial health

As far as the stress response is concerned, an analysis performed by researchers in China after the COVID-19 outbreak found gender disparities in symptom expression. In the study (n = 1,210) the researchers found in female citizens a greater frequency of behavioral manifestations, including acute stress reaction, and symptoms of anxiety and mood disorders – namely, depression.7 Patient perception and awareness of the perils of coronavirus typically varied across the spectrum; some individuals reportedly undermined and devalued their risk of contracting COVID-19 – these patients may benefit from therapeutic modalities, such as cognitive-behavioral therapy (CBT), as a means of challenging their firmly entrenched cognitive distortions. CBT is an effective tool in addressing maladaptive coping responses, because these strategies tend to correspond with poor prognosis with respect to overall mental health. Aside from CBT, the clinician may advise other behavioral techniques, such as relaxation training, with the aim of controlling the symptoms of mood and anxiety disorders.

Dr. Zia Choudhry

We often take for granted general pandemic safety precautions, such as maintaining physical distancing coupled with engaging in regular hand hygiene and wearing masks, but these actions also are known to alleviate mental anguish. Access to accurate and easy-to-consume health information regarding COVID-19 is also associated with psychological well-being during the quarantine.8

An intriguing “phenomenon” has emerged in the form of “panic buying.”However, researchers reported in the peer-reviewed journal Nature Human Behaviour that this pattern of behaviors is not typical for those under distress and represents an overstated misnomer of sorts. According to Jay J. Van Bavel, PhD, and associates, prevailing reports from news outlets have skewed the features of a panic. “News stories that employ the language of panic often create the very phenomena that they purport to condemn,” Dr. Van Bavel and associates wrote. “They can foster the very individualism and competitiveness that turn sensible preparations into dysfunctional stockpiling and undermine the sense of collective purpose which facilitates people supporting one another during an emergency.”9

The researchers proceeded to highlight the scope of effective crisis leadership with respect to establishing a sense of communal “self-efficacy and hope.” The influence of organized leadership serves to solidify the structure of the community as a whole, allowing group members the opportunity to address the stressors of interest. Such leadership may mitigate the stress response by fostering a necessary, healthy set for stress management.



Strategies aimed at supporting mental health

Coping and stress management strategies may include the process of building virtual networks (e.g., social media platforms) because physical distancing may contribute toward further isolation and social estrangement. However, it should be noted that ideally social media consumption should be centered upon interactive enrichment activities that provide a suitable substitute for the absence of physical support systems. The goal is to facilitate meaningful relationships and enduring communications that produce healthy and resilient mindsets.

In particular, individuals who possess adaptive mindsets with a realistic view of ongoing psychosocial stressors, be it from the impact of the pandemic or other influential events, are more likely to benefit when moving forward with life. In other words, the individual in question leverages these experiences as a means of “stress-related growth,” thereby enhancing the overall quality of relationships. Tentative studies in stress management have yielded promising support for interventions that aim to modulate mindsets (as a function of the stress response) by proper appraisal of the stress stimuli, according to Dr. Van Bavel and associates.
 

 

 

Employing assessment scales

To mitigate the stress response, clinicians need to use the relevant stress scales for assessing the full impact of distress brought on by COVID-19 and optimizing therapeutic modalities for those who need them most. Again, the stress response would vary, depending on the patient, and may include paranoia, xenophobia, compulsive ritualistic behavior, as well as full-fledged symptoms of acute stress disorder/PTSD.Steven Taylor, PhD, RPsych, and associates, part of a research team funded by the Canadian Institutes of Health Research and the University of Regina (Sask.), formulated their proprietary COVID Stress Scales (CSS) based on 36 items pertaining to individual anxiety and/or stress responses.10

As general purpose pandemic scales, the assessment tools will be transferable to similar outbreaks, and have been examined for validity and reliability. Additional validation scales include the Patient Health Questionnaire–4 for anxiety and depression, the Short Health Anxiety Inventory for anxiety (irrespective of physical condition), and the Marlowe-Crowne Social Desirability Scale–Short Form for psychological well-being based on the presence (or the lack thereof) of desirable characteristics.10 As a composite scale and predictive tool (especially with respect to future pandemics), the CSS allows clinicians a means of identifying the people who are most compliant with safety procedures, social distancing, hygiene expectations, and vaccine protocols – when applicable – reported Dr. Taylor and associates.
 

Moving forward: The next step in COVID-19 preparedness

As clinicians continue to develop guidelines that are befitting of COVID-19’s “new normal,” a holistic psychosocial framework will need to integrate the various psychometrics gathered from assessment scales, as well as understanding trauma, especially with respect to the HPA axis.

For starters, there is a certain element of “anticipatory anxiety” for those experiencing distress from COVID-19. A highly uncertain future with no immediate cure in the future, isolation and social estrangement, as well as financial setbacks, compound the situation. Moreover, the DSM fails to acknowledge other sources of traumatic experiences that are systemic in nature, such as discriminatory practices, injustice, and/or persecution.

It has also been noted that some distressed individuals experience a hypervigilant state that is comparable with PTSD.11 There may be a push to incorporate machine learning and other modalities to better identify those at risk (for example, health care professionals who perform their duties with limited resources, thereby inducing sleep dysregulation, anxiety, and hopelessness) for mental health deterioration. Interventions may need to be coordinated in a timely manner to disrupt the progression of acute stress disorder to PTSD. Peer support programs and resiliency training – successful therapeutic approaches for PTSD – may prove to have considerable utility for mitigating the overall stress response of COVID-19.12

References

1. “Red Cross offering online course to manage crisis-related stress.” ABC 6 News. kaaltv.com, 2020 Aug 29.

2. Islam FA, Choudhry C. J Psychiatry Psychiatric Disord 2017;1(5): 290-3.

3. Faravelli C et al. World J Psychiatry. 2012 Feb 22;2(1):13-25.

4. Carmassi C et al. Psychiatry Res. 2015 Jan 30;225(1-2):64-9.

5. Pal R. Endocrine. 2020 Apr 28. doi: 10.1007/s12020-020-02325-1.

6. Steenblock C et al. Mol Psychiatry. 2020 May. doi: 10.1038/s41380-020-0758-9.

7. Wang C et al. Int J Environ Res Public Health. 2020 Jan;17(5):1729.

8. Ho CS et al. Ann Acad Med Singap. 2020 Mar 16;49(3):155-60.

9. Van Bavel JJ et al. Nat Hum Behav. 2020 Apr 30. doi: 10.1038/s41562-020-0884-z.

10. Taylor S et al. J Anxiety Disord. 2020 May 4;72:102232.

11. Horesh D, Brown AD. Psychol Trauma. 2020 May;12(4):331-5.

12. Clark H et al. National Health Library and Knowledge Service/Evidence Team. Summary of Evidence: COVID-19, 2020 May 22. Version 2.0.

Dr. Faisal A. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Mohammed S. Islam is a research physician and extern at Interfaith Medical Center, New York. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. Dr. Jolayemi is an attending psychiatrist at Interfaith Medical Center. No disclosures were reported.

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Exorcising your ghosts

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The COVID-19 pandemic has affected private medical practices on so many levels, not least of which is the loss of employees to illness, fear of illness, early retirement, and other reasons. With so many practices forced to hire replacements, basically at the same time, it’s not surprising to see a significant and frustrating increase in ghosting.

ismagilov/iStock/Getty Images Plus

If you’re not hip to the slang, “ghosting” is the situation in which an employee disappears without any warning, notice, or explanation. It usually occurs after a candidate accepts a job offer, and you schedule their first day of work. That day dawns, but the new hire never arrives. Less commonly, an employee who has been with you for some time simply stops showing up and cannot be contacted.



Many employers think of ghosting as a relatively new phenomenon, and blame it on the irresponsibility of younger age groups – millennials, in particular. In fact, it has been an issue for many years across all age groups, and employers often share more of the responsibility than they think.

While total prevention is impossible, there are steps you can take as an employer to minimize ghosting in your practice.

  • Your hiring process needs to be efficient. If you wait too long to schedule an interview with a promising candidate or to offer them the job, another job offer could lure them away. At the very least, a lengthy process or a lack of transparency may make the applicant apprehensive about accepting a job with you, particularly if other employers are pursuing them.
  • Keep applicants in the loop. Follow up with every candidate; let them know where they are in your hiring process. Applicants who have no clue whether they have a shot at the job are going to start looking elsewhere. And make sure they know the job description and starting salary from the outset.
  • Talk to new hires before their first day. Contact them personally to see if they have any questions or concerns, and let them know that you’re looking forward to their arrival.
  • Once they start, make them feel welcome. An employee’s first few days on the job set the tone for the rest of the employment relationship. During this time, clearly communicate what the employee can expect from you and what you expect from them. Take time to discuss key issues, such as work schedules, timekeeping practices, how performance is measured, and dress codes. Introduce them to coworkers, and get them started shadowing more experienced staff members.
  • Take a hard look at your supervision and your supervisors. Business people like to say that employees don’t quit their job, they quit their boss. If an employee quits – with or without notice – it may very well be because of a poor working relationship with you or the supervisor. To be effective, you and your supervisors need to be diligent in setting goals, managing performance, and applying workplace rules and policies. Numerous third-party companies provide training and guidance in these areas when needed.
  • Recognize and reward. As I’ve written many times, positive feedback is a simple, low-cost way to improve employee retention. It demonstrates that you value an employee’s contributions and sets an excellent example for other employees. Effective recognition can come from anyone – including patients – and should be given openly. (Another old adage: “Praise publicly, criticize privately.”) It never hurts to catch an employee doing something right and acknowledge it.
  • Don’t jump to conclusions. If a new hire or employee is absent without notice, don’t just assume you’ve been ghosted. There may be extenuating circumstances, such as an emergency or illness. In some states, an employee’s absence is protected under a law where the employee may not be required to provide advance notice, and taking adverse action could violate these laws. Establish procedures for attempting to contact absent employees, and make sure you’re complying with all applicable leave laws before taking any action.

Dr. Joseph S. Eastern

If an employee does abandon their job, think before you act. Comply with all applicable laws. Act consistently with how you’ve handled similar situations in the past. Your attorney should be involved, especially if the decision involves termination. Notify the employee in writing. As with all employment decisions, keep adequate documentation in case the decision is ever challenged, or you need it to support future disciplinary decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures related to this column. Write to him at [email protected].

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The COVID-19 pandemic has affected private medical practices on so many levels, not least of which is the loss of employees to illness, fear of illness, early retirement, and other reasons. With so many practices forced to hire replacements, basically at the same time, it’s not surprising to see a significant and frustrating increase in ghosting.

ismagilov/iStock/Getty Images Plus

If you’re not hip to the slang, “ghosting” is the situation in which an employee disappears without any warning, notice, or explanation. It usually occurs after a candidate accepts a job offer, and you schedule their first day of work. That day dawns, but the new hire never arrives. Less commonly, an employee who has been with you for some time simply stops showing up and cannot be contacted.



Many employers think of ghosting as a relatively new phenomenon, and blame it on the irresponsibility of younger age groups – millennials, in particular. In fact, it has been an issue for many years across all age groups, and employers often share more of the responsibility than they think.

While total prevention is impossible, there are steps you can take as an employer to minimize ghosting in your practice.

  • Your hiring process needs to be efficient. If you wait too long to schedule an interview with a promising candidate or to offer them the job, another job offer could lure them away. At the very least, a lengthy process or a lack of transparency may make the applicant apprehensive about accepting a job with you, particularly if other employers are pursuing them.
  • Keep applicants in the loop. Follow up with every candidate; let them know where they are in your hiring process. Applicants who have no clue whether they have a shot at the job are going to start looking elsewhere. And make sure they know the job description and starting salary from the outset.
  • Talk to new hires before their first day. Contact them personally to see if they have any questions or concerns, and let them know that you’re looking forward to their arrival.
  • Once they start, make them feel welcome. An employee’s first few days on the job set the tone for the rest of the employment relationship. During this time, clearly communicate what the employee can expect from you and what you expect from them. Take time to discuss key issues, such as work schedules, timekeeping practices, how performance is measured, and dress codes. Introduce them to coworkers, and get them started shadowing more experienced staff members.
  • Take a hard look at your supervision and your supervisors. Business people like to say that employees don’t quit their job, they quit their boss. If an employee quits – with or without notice – it may very well be because of a poor working relationship with you or the supervisor. To be effective, you and your supervisors need to be diligent in setting goals, managing performance, and applying workplace rules and policies. Numerous third-party companies provide training and guidance in these areas when needed.
  • Recognize and reward. As I’ve written many times, positive feedback is a simple, low-cost way to improve employee retention. It demonstrates that you value an employee’s contributions and sets an excellent example for other employees. Effective recognition can come from anyone – including patients – and should be given openly. (Another old adage: “Praise publicly, criticize privately.”) It never hurts to catch an employee doing something right and acknowledge it.
  • Don’t jump to conclusions. If a new hire or employee is absent without notice, don’t just assume you’ve been ghosted. There may be extenuating circumstances, such as an emergency or illness. In some states, an employee’s absence is protected under a law where the employee may not be required to provide advance notice, and taking adverse action could violate these laws. Establish procedures for attempting to contact absent employees, and make sure you’re complying with all applicable leave laws before taking any action.

Dr. Joseph S. Eastern

If an employee does abandon their job, think before you act. Comply with all applicable laws. Act consistently with how you’ve handled similar situations in the past. Your attorney should be involved, especially if the decision involves termination. Notify the employee in writing. As with all employment decisions, keep adequate documentation in case the decision is ever challenged, or you need it to support future disciplinary decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures related to this column. Write to him at [email protected].

The COVID-19 pandemic has affected private medical practices on so many levels, not least of which is the loss of employees to illness, fear of illness, early retirement, and other reasons. With so many practices forced to hire replacements, basically at the same time, it’s not surprising to see a significant and frustrating increase in ghosting.

ismagilov/iStock/Getty Images Plus

If you’re not hip to the slang, “ghosting” is the situation in which an employee disappears without any warning, notice, or explanation. It usually occurs after a candidate accepts a job offer, and you schedule their first day of work. That day dawns, but the new hire never arrives. Less commonly, an employee who has been with you for some time simply stops showing up and cannot be contacted.



Many employers think of ghosting as a relatively new phenomenon, and blame it on the irresponsibility of younger age groups – millennials, in particular. In fact, it has been an issue for many years across all age groups, and employers often share more of the responsibility than they think.

While total prevention is impossible, there are steps you can take as an employer to minimize ghosting in your practice.

  • Your hiring process needs to be efficient. If you wait too long to schedule an interview with a promising candidate or to offer them the job, another job offer could lure them away. At the very least, a lengthy process or a lack of transparency may make the applicant apprehensive about accepting a job with you, particularly if other employers are pursuing them.
  • Keep applicants in the loop. Follow up with every candidate; let them know where they are in your hiring process. Applicants who have no clue whether they have a shot at the job are going to start looking elsewhere. And make sure they know the job description and starting salary from the outset.
  • Talk to new hires before their first day. Contact them personally to see if they have any questions or concerns, and let them know that you’re looking forward to their arrival.
  • Once they start, make them feel welcome. An employee’s first few days on the job set the tone for the rest of the employment relationship. During this time, clearly communicate what the employee can expect from you and what you expect from them. Take time to discuss key issues, such as work schedules, timekeeping practices, how performance is measured, and dress codes. Introduce them to coworkers, and get them started shadowing more experienced staff members.
  • Take a hard look at your supervision and your supervisors. Business people like to say that employees don’t quit their job, they quit their boss. If an employee quits – with or without notice – it may very well be because of a poor working relationship with you or the supervisor. To be effective, you and your supervisors need to be diligent in setting goals, managing performance, and applying workplace rules and policies. Numerous third-party companies provide training and guidance in these areas when needed.
  • Recognize and reward. As I’ve written many times, positive feedback is a simple, low-cost way to improve employee retention. It demonstrates that you value an employee’s contributions and sets an excellent example for other employees. Effective recognition can come from anyone – including patients – and should be given openly. (Another old adage: “Praise publicly, criticize privately.”) It never hurts to catch an employee doing something right and acknowledge it.
  • Don’t jump to conclusions. If a new hire or employee is absent without notice, don’t just assume you’ve been ghosted. There may be extenuating circumstances, such as an emergency or illness. In some states, an employee’s absence is protected under a law where the employee may not be required to provide advance notice, and taking adverse action could violate these laws. Establish procedures for attempting to contact absent employees, and make sure you’re complying with all applicable leave laws before taking any action.

Dr. Joseph S. Eastern

If an employee does abandon their job, think before you act. Comply with all applicable laws. Act consistently with how you’ve handled similar situations in the past. Your attorney should be involved, especially if the decision involves termination. Notify the employee in writing. As with all employment decisions, keep adequate documentation in case the decision is ever challenged, or you need it to support future disciplinary decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures related to this column. Write to him at [email protected].

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Can experiencing bigotry and racism lead to PTSD?

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I have been studying, writing about, and treating posttraumatic stress disorder for many years. Over this time, I have seen PTSD expand to more and more areas of life, including my own view of a “subthreshold” version, which occurs in vulnerable people who experience a job loss, divorce, financial setbacks, or any number of painful life events.

Dr. Robert T. London

As I noted in my recent book, “Find Freedom Fast,” for some people, PTSD can be triggered in the wake of events that are not life-threatening yet catastrophic for them and not tied to manmade or natural disasters, torture, assault, or war zone experiences.

The expansion of PTSD has led to the disorder being recognized in ICU patients during and after recovery (Crit Care Med. 2015 May;43[5]:1121-9), as well as in people diagnosed with cancer (Lancet Psychiatry. 2017 Apr;4[4]:330-8) and other illnesses that may cause emotional trauma – where one feels that one’s life is threatened. In some instances, the person’s life might indeed be in danger, not unlike what can happen in disasters, wars, torture, and even in some encounters with law enforcement.

This leads me to yet another circumstance that in some, may be tied to PTSD – and that is racial, religious, ethnic, and gender-related bigotry. In these cases, individuals feel threatened just for who they are in a society. Being on the receiving end of a circumstance that threatens a person’s very existence would seem to me to place a person as a potential survivor of PTSD, as well as any number of disorders, including anxiety, depression, or even paranoia.

Yes, discrimination and prejudice have been with us for a long time, and what concerns me is the psychological effect it has on children as well as adults. Friends of Irish descent remind me of hearing stories from parents and grandparents about employment signs reading, “Irish need not apply.” Certainly, those of Italian ancestry will easily recall the prejudice focused against them. And members of the Jewish community also can easily remember the bigotry and exclusion they have been subject to in certain neighborhoods and organizations, in addition to the horrors of the Holocaust during World War II, and the anti-Semitic chants in Charlottesville, Va., from just 3 years ago – with gun-carrying militants doing the chanting.

Obviously, in certain circles, we still have private clubs, plus neighborhoods and residential buildings that exclude people for a variety of reasons.

Coming from a medical family, years ago I heard stories that, if you were Roman Catholic, it would be hard to get into certain medical schools – which might explain the establishment of Catholic medical schools that often were open to people of other faiths. Then we had medical school discrimination toward Jewish students, which was followed by the establishment of medical schools focused on admitting more Jewish students. The African American community also responded to discrimination by establishing medical schools, such as the school at Howard University in Washington.

Furthermore, we cannot forget the discrimination that women faced in institutions of higher learning. My father had two women in his medical school class, I was told. In my era, I would say at least 30% were women, and today, in the United States, medical school classes are more equally balanced with men and women. Some schools have more women than men.

The question I ask, is: How did all those women feel for so many years knowing that, for reasons beyond their control, they were prevented from achieving their chosen goals? Some might have felt badly, and others might have internalized the rejection. Others might have developed PTSD based on feelings of rejection.

However, the question here mainly is: Can PTSD result when exclusion and prejudice induce fear and terror in those on the receiving end – especially innocent children? Children separated from their parents at the U.S.-Mexico border and those who witness their parents being shot immediately come to mind. This trauma can last well beyond childhood.

What we know today about structural racism should give the mental health community pause and make us realize the extent to which the African American community has been traumatized. Perhaps we should not be surprised by a study that found that the prevalence of PTSD among African Americans is 9.1%, compared with 6.8% for Whites (J Anxiety Dis. 2009 Jun;23[5]:573-90). Speaking with Black colleagues, friends, and patients, reading books such “The Warmth of Other Suns,” and watching films such as “Green Book,” give us a sense of how dangerous it was for Black families to travel in certain parts of the country in the recent past. I recall as a child hearing that, in Miami Beach, people of color could not stay overnight. (Even as a child I was surprised – having never heard anything like that. After all, I went to school with people of many religions and backgrounds. My parents thought those practices were terrible, and were appalled when they learned that some hotels were closed to Jews and others closed to Catholics.)
 

 

 

DSM-5, ICD-10 fall short

The DSM-5 describes trauma using a more or less one-dimensional set of guidelines as the focus. Those guidelines include exposure to direct violence, manmade or natural disasters, war, or torture, as well as exposure to a disaster or a life-threatening situation affecting a loved one. The ICD-10 is less restrictive about trauma but still has some limitations.

While considering potential PTSD, I try to use a less rigid diagnostic multidimensional approach, where I assess individual differences and experiences that play a role in those experiences as well as the patient’s vulnerability to the causation of PTSD – which also has to include any exposure to trauma (Curr Opin Psychol. 2017 Apr;14:29-34) before age 11 or 12. The data suggest that such early exposure leaves people more vulnerable to PTSD as adults (Soc Sci Med. 2018 Feb;199:230-40).

In my view, if individuals are frightened because of who they are – be it tied to their religion, race, sexual identity, or ethnicity – and what harm may come to them, and if they live in fear and avoidance of these potential traumatic situations that affect their mental stability and the way they live their lives, they might fit the PTSD model.

If we clinicians focus on what’s currently being brought vividly into the public eye today regarding the African American community, we would see that some of the ongoing fears of racism – whether tied to residential or workplace discrimination, unfair treatment by figures of authority, harassment, health inequities, or microaggressions – may give rise to PTSD. I know we can do better. We should broaden our definition and awareness of this very serious disorder – and be prepared to treat it.
 

Dr. London has been a practicing psychiatrist for 4 decades and a newspaper columnist for almost as long. He has a private practice in New York and is author of “Find Freedom Fast: Short-Term Therapy That Works” (New York: Kettlehole Publishing, 2019). Dr. London has no conflicts of interest.

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I have been studying, writing about, and treating posttraumatic stress disorder for many years. Over this time, I have seen PTSD expand to more and more areas of life, including my own view of a “subthreshold” version, which occurs in vulnerable people who experience a job loss, divorce, financial setbacks, or any number of painful life events.

Dr. Robert T. London

As I noted in my recent book, “Find Freedom Fast,” for some people, PTSD can be triggered in the wake of events that are not life-threatening yet catastrophic for them and not tied to manmade or natural disasters, torture, assault, or war zone experiences.

The expansion of PTSD has led to the disorder being recognized in ICU patients during and after recovery (Crit Care Med. 2015 May;43[5]:1121-9), as well as in people diagnosed with cancer (Lancet Psychiatry. 2017 Apr;4[4]:330-8) and other illnesses that may cause emotional trauma – where one feels that one’s life is threatened. In some instances, the person’s life might indeed be in danger, not unlike what can happen in disasters, wars, torture, and even in some encounters with law enforcement.

This leads me to yet another circumstance that in some, may be tied to PTSD – and that is racial, religious, ethnic, and gender-related bigotry. In these cases, individuals feel threatened just for who they are in a society. Being on the receiving end of a circumstance that threatens a person’s very existence would seem to me to place a person as a potential survivor of PTSD, as well as any number of disorders, including anxiety, depression, or even paranoia.

Yes, discrimination and prejudice have been with us for a long time, and what concerns me is the psychological effect it has on children as well as adults. Friends of Irish descent remind me of hearing stories from parents and grandparents about employment signs reading, “Irish need not apply.” Certainly, those of Italian ancestry will easily recall the prejudice focused against them. And members of the Jewish community also can easily remember the bigotry and exclusion they have been subject to in certain neighborhoods and organizations, in addition to the horrors of the Holocaust during World War II, and the anti-Semitic chants in Charlottesville, Va., from just 3 years ago – with gun-carrying militants doing the chanting.

Obviously, in certain circles, we still have private clubs, plus neighborhoods and residential buildings that exclude people for a variety of reasons.

Coming from a medical family, years ago I heard stories that, if you were Roman Catholic, it would be hard to get into certain medical schools – which might explain the establishment of Catholic medical schools that often were open to people of other faiths. Then we had medical school discrimination toward Jewish students, which was followed by the establishment of medical schools focused on admitting more Jewish students. The African American community also responded to discrimination by establishing medical schools, such as the school at Howard University in Washington.

Furthermore, we cannot forget the discrimination that women faced in institutions of higher learning. My father had two women in his medical school class, I was told. In my era, I would say at least 30% were women, and today, in the United States, medical school classes are more equally balanced with men and women. Some schools have more women than men.

The question I ask, is: How did all those women feel for so many years knowing that, for reasons beyond their control, they were prevented from achieving their chosen goals? Some might have felt badly, and others might have internalized the rejection. Others might have developed PTSD based on feelings of rejection.

However, the question here mainly is: Can PTSD result when exclusion and prejudice induce fear and terror in those on the receiving end – especially innocent children? Children separated from their parents at the U.S.-Mexico border and those who witness their parents being shot immediately come to mind. This trauma can last well beyond childhood.

What we know today about structural racism should give the mental health community pause and make us realize the extent to which the African American community has been traumatized. Perhaps we should not be surprised by a study that found that the prevalence of PTSD among African Americans is 9.1%, compared with 6.8% for Whites (J Anxiety Dis. 2009 Jun;23[5]:573-90). Speaking with Black colleagues, friends, and patients, reading books such “The Warmth of Other Suns,” and watching films such as “Green Book,” give us a sense of how dangerous it was for Black families to travel in certain parts of the country in the recent past. I recall as a child hearing that, in Miami Beach, people of color could not stay overnight. (Even as a child I was surprised – having never heard anything like that. After all, I went to school with people of many religions and backgrounds. My parents thought those practices were terrible, and were appalled when they learned that some hotels were closed to Jews and others closed to Catholics.)
 

 

 

DSM-5, ICD-10 fall short

The DSM-5 describes trauma using a more or less one-dimensional set of guidelines as the focus. Those guidelines include exposure to direct violence, manmade or natural disasters, war, or torture, as well as exposure to a disaster or a life-threatening situation affecting a loved one. The ICD-10 is less restrictive about trauma but still has some limitations.

While considering potential PTSD, I try to use a less rigid diagnostic multidimensional approach, where I assess individual differences and experiences that play a role in those experiences as well as the patient’s vulnerability to the causation of PTSD – which also has to include any exposure to trauma (Curr Opin Psychol. 2017 Apr;14:29-34) before age 11 or 12. The data suggest that such early exposure leaves people more vulnerable to PTSD as adults (Soc Sci Med. 2018 Feb;199:230-40).

In my view, if individuals are frightened because of who they are – be it tied to their religion, race, sexual identity, or ethnicity – and what harm may come to them, and if they live in fear and avoidance of these potential traumatic situations that affect their mental stability and the way they live their lives, they might fit the PTSD model.

If we clinicians focus on what’s currently being brought vividly into the public eye today regarding the African American community, we would see that some of the ongoing fears of racism – whether tied to residential or workplace discrimination, unfair treatment by figures of authority, harassment, health inequities, or microaggressions – may give rise to PTSD. I know we can do better. We should broaden our definition and awareness of this very serious disorder – and be prepared to treat it.
 

Dr. London has been a practicing psychiatrist for 4 decades and a newspaper columnist for almost as long. He has a private practice in New York and is author of “Find Freedom Fast: Short-Term Therapy That Works” (New York: Kettlehole Publishing, 2019). Dr. London has no conflicts of interest.

I have been studying, writing about, and treating posttraumatic stress disorder for many years. Over this time, I have seen PTSD expand to more and more areas of life, including my own view of a “subthreshold” version, which occurs in vulnerable people who experience a job loss, divorce, financial setbacks, or any number of painful life events.

Dr. Robert T. London

As I noted in my recent book, “Find Freedom Fast,” for some people, PTSD can be triggered in the wake of events that are not life-threatening yet catastrophic for them and not tied to manmade or natural disasters, torture, assault, or war zone experiences.

The expansion of PTSD has led to the disorder being recognized in ICU patients during and after recovery (Crit Care Med. 2015 May;43[5]:1121-9), as well as in people diagnosed with cancer (Lancet Psychiatry. 2017 Apr;4[4]:330-8) and other illnesses that may cause emotional trauma – where one feels that one’s life is threatened. In some instances, the person’s life might indeed be in danger, not unlike what can happen in disasters, wars, torture, and even in some encounters with law enforcement.

This leads me to yet another circumstance that in some, may be tied to PTSD – and that is racial, religious, ethnic, and gender-related bigotry. In these cases, individuals feel threatened just for who they are in a society. Being on the receiving end of a circumstance that threatens a person’s very existence would seem to me to place a person as a potential survivor of PTSD, as well as any number of disorders, including anxiety, depression, or even paranoia.

Yes, discrimination and prejudice have been with us for a long time, and what concerns me is the psychological effect it has on children as well as adults. Friends of Irish descent remind me of hearing stories from parents and grandparents about employment signs reading, “Irish need not apply.” Certainly, those of Italian ancestry will easily recall the prejudice focused against them. And members of the Jewish community also can easily remember the bigotry and exclusion they have been subject to in certain neighborhoods and organizations, in addition to the horrors of the Holocaust during World War II, and the anti-Semitic chants in Charlottesville, Va., from just 3 years ago – with gun-carrying militants doing the chanting.

Obviously, in certain circles, we still have private clubs, plus neighborhoods and residential buildings that exclude people for a variety of reasons.

Coming from a medical family, years ago I heard stories that, if you were Roman Catholic, it would be hard to get into certain medical schools – which might explain the establishment of Catholic medical schools that often were open to people of other faiths. Then we had medical school discrimination toward Jewish students, which was followed by the establishment of medical schools focused on admitting more Jewish students. The African American community also responded to discrimination by establishing medical schools, such as the school at Howard University in Washington.

Furthermore, we cannot forget the discrimination that women faced in institutions of higher learning. My father had two women in his medical school class, I was told. In my era, I would say at least 30% were women, and today, in the United States, medical school classes are more equally balanced with men and women. Some schools have more women than men.

The question I ask, is: How did all those women feel for so many years knowing that, for reasons beyond their control, they were prevented from achieving their chosen goals? Some might have felt badly, and others might have internalized the rejection. Others might have developed PTSD based on feelings of rejection.

However, the question here mainly is: Can PTSD result when exclusion and prejudice induce fear and terror in those on the receiving end – especially innocent children? Children separated from their parents at the U.S.-Mexico border and those who witness their parents being shot immediately come to mind. This trauma can last well beyond childhood.

What we know today about structural racism should give the mental health community pause and make us realize the extent to which the African American community has been traumatized. Perhaps we should not be surprised by a study that found that the prevalence of PTSD among African Americans is 9.1%, compared with 6.8% for Whites (J Anxiety Dis. 2009 Jun;23[5]:573-90). Speaking with Black colleagues, friends, and patients, reading books such “The Warmth of Other Suns,” and watching films such as “Green Book,” give us a sense of how dangerous it was for Black families to travel in certain parts of the country in the recent past. I recall as a child hearing that, in Miami Beach, people of color could not stay overnight. (Even as a child I was surprised – having never heard anything like that. After all, I went to school with people of many religions and backgrounds. My parents thought those practices were terrible, and were appalled when they learned that some hotels were closed to Jews and others closed to Catholics.)
 

 

 

DSM-5, ICD-10 fall short

The DSM-5 describes trauma using a more or less one-dimensional set of guidelines as the focus. Those guidelines include exposure to direct violence, manmade or natural disasters, war, or torture, as well as exposure to a disaster or a life-threatening situation affecting a loved one. The ICD-10 is less restrictive about trauma but still has some limitations.

While considering potential PTSD, I try to use a less rigid diagnostic multidimensional approach, where I assess individual differences and experiences that play a role in those experiences as well as the patient’s vulnerability to the causation of PTSD – which also has to include any exposure to trauma (Curr Opin Psychol. 2017 Apr;14:29-34) before age 11 or 12. The data suggest that such early exposure leaves people more vulnerable to PTSD as adults (Soc Sci Med. 2018 Feb;199:230-40).

In my view, if individuals are frightened because of who they are – be it tied to their religion, race, sexual identity, or ethnicity – and what harm may come to them, and if they live in fear and avoidance of these potential traumatic situations that affect their mental stability and the way they live their lives, they might fit the PTSD model.

If we clinicians focus on what’s currently being brought vividly into the public eye today regarding the African American community, we would see that some of the ongoing fears of racism – whether tied to residential or workplace discrimination, unfair treatment by figures of authority, harassment, health inequities, or microaggressions – may give rise to PTSD. I know we can do better. We should broaden our definition and awareness of this very serious disorder – and be prepared to treat it.
 

Dr. London has been a practicing psychiatrist for 4 decades and a newspaper columnist for almost as long. He has a private practice in New York and is author of “Find Freedom Fast: Short-Term Therapy That Works” (New York: Kettlehole Publishing, 2019). Dr. London has no conflicts of interest.

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Use of 3D Technology to Support Dermatologists Returning to Practice Amid COVID-19

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Coronavirus disease 2019 (COVID-19) has spread across all 7 continents, including 185 countries, and infected more than 21.9 million individuals worldwide as of August 18, 2020, according to the Johns Hopkins Coronavirus Resource Center. It has strained our health care system and affected all specialties, including dermatology. Dermatologists have taken important safety measures by canceling/deferring elective and nonemergency procedures and diagnosing/treating patients via telemedicine. Many residents and attending dermatologists have volunteered to care for COVID-19 inpatients and donated personal protective equipment (PPE) to hospitals reporting shortages.1 As we prepare to treat increasing numbers of in-office patients, there will be a critical need for PPE. We highlight the use of 3-dimensional (3D) imaging and printing technologies as it applies to the dermatology outpatient setting.

N95 masks are necessary during the COVID-19 pandemic because they effectively filter at least 95% of 0.3-μm airborne particles and provide adequate face seals.1 3-Dimensional imaging integrated with 3D printers can be used to scan precise facial parameters (eg, jawline, nose) and account for facial hair density and length to produce comfortable tailored N95 masks and face seals.1,2 3-Dimensional printing utilizes robotics and computer-aided design systems to layer and deposit biomaterials, thereby creating cost-effective, customizable, mechanically stable, and biocompatible constructs.1,3 An ideal 3D-printed N95 mask would be printed via fused deposition modeling, consisting of a combination of lightweight and fatigue-resistant biomaterials, including electrostatic nonwoven polypropylene and styrene-(ethylene-butylene)-styrene.1,4 The resulting masks, made from industrial-grade raw materials, are practical alternatives for dermatology practices with insufficient supplies.

Face shields offer an additional layer of safety for the face and mucosae and also may provide longevity for N95 masks. Using synthetic polymers such as polycarbonate and polyethylene, 3D printers can be used to construct face shields via fused deposition modeling.1 These face shields may be worn over N95 masks and then can be sanitized and reused.

Mohs surgeons and staff may be at particularly high risk for COVID-19 infection due to their close proximity to the face during surgery, use of cautery, and prolonged time spent with patients while taking layers and suturing. Multispectral optoacoustic tomography is a noninvasive imaging tool that can map skin tumors via optical contrast with accuracy comparable to histologic measurements.5 3-Dimensional facial imaging and printing can be used to calculate tumor surface area for customized masks, leaving sufficient skin for excision and reconstruction. Patient face coverings would cover the nose and mouth, only expose relevant areas near the excision site, and include adjustable/removable ear loops for tumors localized to the ears. A schematic of how 3D technologies can be applied for Mohs micrographic surgery is provided in the Figure.

3-Dimensional (3D) imaging technologies and a 3D-printed face covering prototype that can potentially be used on patients during Mohs micrographic surgery. The biomaterials in this diagram have been well tested in the literature and are the same materials that are used in N95 masks.


As dermatologists reopen and ramp up practice volume, there will be increased PPE requirements. Using 3D technology and imaging to produce N95 masks, face shields, and face coverings, we can offer effective diagnosis and treatment while optimizing safety for dermatologists, staff, and patients.
References
  1. Ishack S, Lipner SR. Applications of 3D printing technology to address COVID-19-related supply shortages [published online April 21, 2020]. Am J Med. 2020;133:771-773.
  2. Cai M, Li H, Shen S, et al. Customized design and 3D printing of face seal for an N95 filtering facepiece respirator. J Occup Environ Hyg. 2018;3:226-234.
  3. Ishack S, Lipner SR. A review of 3-dimensional skin bioprinting techniques: applications, approaches, and trends [published online March 17, 2020]. Dermatol Surg. doi:10.1097/DSS.0000000000002378.
  4. Banerjee SS, Burbine S, Shivaprakash NK, et al. 3D-printable PP/SEBS thermoplastic elastomeric blends: preparation and properties [published online February 17, 2019]. Polymers (Basel). doi:10.3390/polym11020347.
  5. Chuah SY, Attia ABE, Long V. Structural and functional 3D mapping of skin tumours with non-invasive multispectral optoacoustic tomography [published online November 2, 2016]. Skin Res Technol. 2017;23:221-226.
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Dr. Ishack is from the New York University School of Medicine, New York. Dr. Lipner is from the Department of Dermatology, Weill Cornell Medical College, New York.

The authors report no conflict of interest.

Correspondence: Shari R. Lipner, MD, PhD, 1305 York Ave, New York, NY 10021 ([email protected]).

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Correspondence: Shari R. Lipner, MD, PhD, 1305 York Ave, New York, NY 10021 ([email protected]).

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Dr. Ishack is from the New York University School of Medicine, New York. Dr. Lipner is from the Department of Dermatology, Weill Cornell Medical College, New York.

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Coronavirus disease 2019 (COVID-19) has spread across all 7 continents, including 185 countries, and infected more than 21.9 million individuals worldwide as of August 18, 2020, according to the Johns Hopkins Coronavirus Resource Center. It has strained our health care system and affected all specialties, including dermatology. Dermatologists have taken important safety measures by canceling/deferring elective and nonemergency procedures and diagnosing/treating patients via telemedicine. Many residents and attending dermatologists have volunteered to care for COVID-19 inpatients and donated personal protective equipment (PPE) to hospitals reporting shortages.1 As we prepare to treat increasing numbers of in-office patients, there will be a critical need for PPE. We highlight the use of 3-dimensional (3D) imaging and printing technologies as it applies to the dermatology outpatient setting.

N95 masks are necessary during the COVID-19 pandemic because they effectively filter at least 95% of 0.3-μm airborne particles and provide adequate face seals.1 3-Dimensional imaging integrated with 3D printers can be used to scan precise facial parameters (eg, jawline, nose) and account for facial hair density and length to produce comfortable tailored N95 masks and face seals.1,2 3-Dimensional printing utilizes robotics and computer-aided design systems to layer and deposit biomaterials, thereby creating cost-effective, customizable, mechanically stable, and biocompatible constructs.1,3 An ideal 3D-printed N95 mask would be printed via fused deposition modeling, consisting of a combination of lightweight and fatigue-resistant biomaterials, including electrostatic nonwoven polypropylene and styrene-(ethylene-butylene)-styrene.1,4 The resulting masks, made from industrial-grade raw materials, are practical alternatives for dermatology practices with insufficient supplies.

Face shields offer an additional layer of safety for the face and mucosae and also may provide longevity for N95 masks. Using synthetic polymers such as polycarbonate and polyethylene, 3D printers can be used to construct face shields via fused deposition modeling.1 These face shields may be worn over N95 masks and then can be sanitized and reused.

Mohs surgeons and staff may be at particularly high risk for COVID-19 infection due to their close proximity to the face during surgery, use of cautery, and prolonged time spent with patients while taking layers and suturing. Multispectral optoacoustic tomography is a noninvasive imaging tool that can map skin tumors via optical contrast with accuracy comparable to histologic measurements.5 3-Dimensional facial imaging and printing can be used to calculate tumor surface area for customized masks, leaving sufficient skin for excision and reconstruction. Patient face coverings would cover the nose and mouth, only expose relevant areas near the excision site, and include adjustable/removable ear loops for tumors localized to the ears. A schematic of how 3D technologies can be applied for Mohs micrographic surgery is provided in the Figure.

3-Dimensional (3D) imaging technologies and a 3D-printed face covering prototype that can potentially be used on patients during Mohs micrographic surgery. The biomaterials in this diagram have been well tested in the literature and are the same materials that are used in N95 masks.


As dermatologists reopen and ramp up practice volume, there will be increased PPE requirements. Using 3D technology and imaging to produce N95 masks, face shields, and face coverings, we can offer effective diagnosis and treatment while optimizing safety for dermatologists, staff, and patients.

 

Coronavirus disease 2019 (COVID-19) has spread across all 7 continents, including 185 countries, and infected more than 21.9 million individuals worldwide as of August 18, 2020, according to the Johns Hopkins Coronavirus Resource Center. It has strained our health care system and affected all specialties, including dermatology. Dermatologists have taken important safety measures by canceling/deferring elective and nonemergency procedures and diagnosing/treating patients via telemedicine. Many residents and attending dermatologists have volunteered to care for COVID-19 inpatients and donated personal protective equipment (PPE) to hospitals reporting shortages.1 As we prepare to treat increasing numbers of in-office patients, there will be a critical need for PPE. We highlight the use of 3-dimensional (3D) imaging and printing technologies as it applies to the dermatology outpatient setting.

N95 masks are necessary during the COVID-19 pandemic because they effectively filter at least 95% of 0.3-μm airborne particles and provide adequate face seals.1 3-Dimensional imaging integrated with 3D printers can be used to scan precise facial parameters (eg, jawline, nose) and account for facial hair density and length to produce comfortable tailored N95 masks and face seals.1,2 3-Dimensional printing utilizes robotics and computer-aided design systems to layer and deposit biomaterials, thereby creating cost-effective, customizable, mechanically stable, and biocompatible constructs.1,3 An ideal 3D-printed N95 mask would be printed via fused deposition modeling, consisting of a combination of lightweight and fatigue-resistant biomaterials, including electrostatic nonwoven polypropylene and styrene-(ethylene-butylene)-styrene.1,4 The resulting masks, made from industrial-grade raw materials, are practical alternatives for dermatology practices with insufficient supplies.

Face shields offer an additional layer of safety for the face and mucosae and also may provide longevity for N95 masks. Using synthetic polymers such as polycarbonate and polyethylene, 3D printers can be used to construct face shields via fused deposition modeling.1 These face shields may be worn over N95 masks and then can be sanitized and reused.

Mohs surgeons and staff may be at particularly high risk for COVID-19 infection due to their close proximity to the face during surgery, use of cautery, and prolonged time spent with patients while taking layers and suturing. Multispectral optoacoustic tomography is a noninvasive imaging tool that can map skin tumors via optical contrast with accuracy comparable to histologic measurements.5 3-Dimensional facial imaging and printing can be used to calculate tumor surface area for customized masks, leaving sufficient skin for excision and reconstruction. Patient face coverings would cover the nose and mouth, only expose relevant areas near the excision site, and include adjustable/removable ear loops for tumors localized to the ears. A schematic of how 3D technologies can be applied for Mohs micrographic surgery is provided in the Figure.

3-Dimensional (3D) imaging technologies and a 3D-printed face covering prototype that can potentially be used on patients during Mohs micrographic surgery. The biomaterials in this diagram have been well tested in the literature and are the same materials that are used in N95 masks.


As dermatologists reopen and ramp up practice volume, there will be increased PPE requirements. Using 3D technology and imaging to produce N95 masks, face shields, and face coverings, we can offer effective diagnosis and treatment while optimizing safety for dermatologists, staff, and patients.
References
  1. Ishack S, Lipner SR. Applications of 3D printing technology to address COVID-19-related supply shortages [published online April 21, 2020]. Am J Med. 2020;133:771-773.
  2. Cai M, Li H, Shen S, et al. Customized design and 3D printing of face seal for an N95 filtering facepiece respirator. J Occup Environ Hyg. 2018;3:226-234.
  3. Ishack S, Lipner SR. A review of 3-dimensional skin bioprinting techniques: applications, approaches, and trends [published online March 17, 2020]. Dermatol Surg. doi:10.1097/DSS.0000000000002378.
  4. Banerjee SS, Burbine S, Shivaprakash NK, et al. 3D-printable PP/SEBS thermoplastic elastomeric blends: preparation and properties [published online February 17, 2019]. Polymers (Basel). doi:10.3390/polym11020347.
  5. Chuah SY, Attia ABE, Long V. Structural and functional 3D mapping of skin tumours with non-invasive multispectral optoacoustic tomography [published online November 2, 2016]. Skin Res Technol. 2017;23:221-226.
References
  1. Ishack S, Lipner SR. Applications of 3D printing technology to address COVID-19-related supply shortages [published online April 21, 2020]. Am J Med. 2020;133:771-773.
  2. Cai M, Li H, Shen S, et al. Customized design and 3D printing of face seal for an N95 filtering facepiece respirator. J Occup Environ Hyg. 2018;3:226-234.
  3. Ishack S, Lipner SR. A review of 3-dimensional skin bioprinting techniques: applications, approaches, and trends [published online March 17, 2020]. Dermatol Surg. doi:10.1097/DSS.0000000000002378.
  4. Banerjee SS, Burbine S, Shivaprakash NK, et al. 3D-printable PP/SEBS thermoplastic elastomeric blends: preparation and properties [published online February 17, 2019]. Polymers (Basel). doi:10.3390/polym11020347.
  5. Chuah SY, Attia ABE, Long V. Structural and functional 3D mapping of skin tumours with non-invasive multispectral optoacoustic tomography [published online November 2, 2016]. Skin Res Technol. 2017;23:221-226.
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  • Coronavirus disease 19 has overwhelmed our health care system and affected all specialties, including dermatology.
  • There are concerns about shortages of personal protective equipment to safely care for patients.
  • 3-Dimensional imaging and printing technologies can be harnessed to create face coverings and face shields for the dermatology outpatient setting.
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Filling Gaps: Moving Toward Better Treatment of Children With Atopic Dermatitis

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It is a brand-new day for the treatment of children with severe inflammatory skin diseases. Not coincidentally, it also is a new day for the treatment of atopic dermatitis (AD). Why?

Historically, children have largely been ignored by pharmaceutical companies and the US Food and Drug Administration (FDA). Drug trials of new medications have been the exclusive province of adults; therefore, information they have generated has had only derivative relevance to the pediatric population. Pediatricians and providers who care for children, aware that they are not simply “little adults,” have been forced to extrapolate best practices.

My institution is poised to enroll a 3-year-old child with severe AD into a biologic trial (ClinicalTrials.gov identifier NCT03346434). The age range for this study is 6 months to 6 years. This extraordinary democratization of clinical trials is no accident. The Best Pharmaceuticals for Children Act, which was passed in 2002, was a first step. This legislation incentivized pharmaceutical companies to include children, who are notoriously more costly to study for myriad reasons, by extending patent protection for approved medications. Subsequent efforts spearheaded by advocacy groups such as the National Eczema Association included the production of guidance documents for industry1 and presentations directly to the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee meeting punctuated by powerful patient testimonials.2

Serendipitously, AD, a disease that presents by kindergarten in up to 90% of affected individuals, also has caught the eye of the pharmaceutical industry. Remarkable advances in the understanding of AD inflammation have led to an explosion of new therapeutic targets of interest. By way of context, between the introduction of topical calcineurin inhibitors in 2001 and the FDA approval of dupilumab and crisaborole in 2017, there were precisely zero new molecules approved for the treatment of AD. Viewed through another lens, prior to 2017, the only FDA-approved systemic medication for AD was prednisone, a drug most AD experts would list as the least appropriate choice for treatment of this condition.

Fast-forward to 2020 and we have a plethora of new possibilities. The National Eczema Association’s research web page (https://nationaleczema.org/research/eczema-treatment-research/) reveals no fewer than 24 systemic agents in phase 2 development or beyond, including selective IL-13 inhibitors such as tralokinumab and lebrikizumab; Janus kinase inhibitors such as baricitinib3; and novel targets such as histamine 4 (ZPL-3893787), IL-31 (nemolizumab), and thymic stromal lymphopoietin. This list does not even include other biologics being repurposed for AD (eg, omalizumab4) or a host of exciting new topical agents (eg, tapinarof).



This confluence of better science, powerful advocacy, and enlightened self-interest has been revolutionary. It is most evident when parents/guardians—many of whom had long ago given up on new therapies for themselves—are gobsmacked by the new therapeutic landscape outlined for their children. Parents/guardians realize their children need not struggle as they may have themselves. The impact on quality of life has long been known, but several recent publications have brought it into finer relief. Drucker et al5 highlighted the overall burden of disease, and several subsequent papers have focused specifically on affective impacts including increased risk for depression, suicidal ideation, and suicide.6,7 In this issue of Cutis, Tracy et al8 provide an update on pediatric AD with an emphasis on comorbidities, quality of life, and evolving practices and therapies.

Better science, better drugs, better advocacy, better outcomes—it has not been a straight line, but it has indisputably been a forward-marching one. It is a new day, indeed.

References
  1. Siegfried EC, Jaworski JC, Eichenfield LF, et al. Developing drugs for the treatment of atopic dermatitis in children (≥3 months to <18 years of age): draft guidance for industry [published online March 30, 2018]. Pediatr Dermatol. 2018; May 35:303-322.
  2. Pediatric trials for AD systemic treatments. Dermatology Times. May 21, 2015. https://www.dermatologytimes.com/view/pediatric-trials-ad-systemic-treatments. Accessed August 11, 2020.
  3. Solimani F, Meier K, Ghoreschi K. Emerging topical and systemic JAK inhibitors in dermatology. Front Immunol. 2019;10:2847.
  4. Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized controlled trial. JAMA Pediatr. 2019;174:29-37.
  5. Drucker AM, Wang AR, Li W-Q, et al. The burden of atopic dermatitis: summary of a report for the National Eczema Association [published online September 8, 2016]. J Invest Dermatol. 2017;137:26-30.
  6. Sandhu JK, Wu KK, Bui T-L, et al. Association between atopic dermatitis and suicidality: a systematic review and meta-analysis. JAMA Dermatol. 2019;155:178-187.
  7. Patel KR, Immaneni S, Singam V, et al. Association between atopic dermatitis, depression, and suicidal ideation: a systematic review and meta-analysis [published online October 23, 2018]. J Am Acad Dermatol. 2019;80:402-410.
  8. Tracy A, Bhatti S, Eichenfield LF. Update on pediatric atopic dermatitis. Cutis. 2020;106:143-146.
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Dr. Sidbury is an investigator for Brickell Biotech, Inc; Galderma Laboratories, LP; and Regeneron Pharmaceuticals. He also is a consultant for Micreos.

Correspondence: Robert Sidbury, MD, MPH ([email protected]).

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Correspondence: Robert Sidbury, MD, MPH ([email protected]).

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Correspondence: Robert Sidbury, MD, MPH ([email protected]).

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It is a brand-new day for the treatment of children with severe inflammatory skin diseases. Not coincidentally, it also is a new day for the treatment of atopic dermatitis (AD). Why?

Historically, children have largely been ignored by pharmaceutical companies and the US Food and Drug Administration (FDA). Drug trials of new medications have been the exclusive province of adults; therefore, information they have generated has had only derivative relevance to the pediatric population. Pediatricians and providers who care for children, aware that they are not simply “little adults,” have been forced to extrapolate best practices.

My institution is poised to enroll a 3-year-old child with severe AD into a biologic trial (ClinicalTrials.gov identifier NCT03346434). The age range for this study is 6 months to 6 years. This extraordinary democratization of clinical trials is no accident. The Best Pharmaceuticals for Children Act, which was passed in 2002, was a first step. This legislation incentivized pharmaceutical companies to include children, who are notoriously more costly to study for myriad reasons, by extending patent protection for approved medications. Subsequent efforts spearheaded by advocacy groups such as the National Eczema Association included the production of guidance documents for industry1 and presentations directly to the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee meeting punctuated by powerful patient testimonials.2

Serendipitously, AD, a disease that presents by kindergarten in up to 90% of affected individuals, also has caught the eye of the pharmaceutical industry. Remarkable advances in the understanding of AD inflammation have led to an explosion of new therapeutic targets of interest. By way of context, between the introduction of topical calcineurin inhibitors in 2001 and the FDA approval of dupilumab and crisaborole in 2017, there were precisely zero new molecules approved for the treatment of AD. Viewed through another lens, prior to 2017, the only FDA-approved systemic medication for AD was prednisone, a drug most AD experts would list as the least appropriate choice for treatment of this condition.

Fast-forward to 2020 and we have a plethora of new possibilities. The National Eczema Association’s research web page (https://nationaleczema.org/research/eczema-treatment-research/) reveals no fewer than 24 systemic agents in phase 2 development or beyond, including selective IL-13 inhibitors such as tralokinumab and lebrikizumab; Janus kinase inhibitors such as baricitinib3; and novel targets such as histamine 4 (ZPL-3893787), IL-31 (nemolizumab), and thymic stromal lymphopoietin. This list does not even include other biologics being repurposed for AD (eg, omalizumab4) or a host of exciting new topical agents (eg, tapinarof).



This confluence of better science, powerful advocacy, and enlightened self-interest has been revolutionary. It is most evident when parents/guardians—many of whom had long ago given up on new therapies for themselves—are gobsmacked by the new therapeutic landscape outlined for their children. Parents/guardians realize their children need not struggle as they may have themselves. The impact on quality of life has long been known, but several recent publications have brought it into finer relief. Drucker et al5 highlighted the overall burden of disease, and several subsequent papers have focused specifically on affective impacts including increased risk for depression, suicidal ideation, and suicide.6,7 In this issue of Cutis, Tracy et al8 provide an update on pediatric AD with an emphasis on comorbidities, quality of life, and evolving practices and therapies.

Better science, better drugs, better advocacy, better outcomes—it has not been a straight line, but it has indisputably been a forward-marching one. It is a new day, indeed.

It is a brand-new day for the treatment of children with severe inflammatory skin diseases. Not coincidentally, it also is a new day for the treatment of atopic dermatitis (AD). Why?

Historically, children have largely been ignored by pharmaceutical companies and the US Food and Drug Administration (FDA). Drug trials of new medications have been the exclusive province of adults; therefore, information they have generated has had only derivative relevance to the pediatric population. Pediatricians and providers who care for children, aware that they are not simply “little adults,” have been forced to extrapolate best practices.

My institution is poised to enroll a 3-year-old child with severe AD into a biologic trial (ClinicalTrials.gov identifier NCT03346434). The age range for this study is 6 months to 6 years. This extraordinary democratization of clinical trials is no accident. The Best Pharmaceuticals for Children Act, which was passed in 2002, was a first step. This legislation incentivized pharmaceutical companies to include children, who are notoriously more costly to study for myriad reasons, by extending patent protection for approved medications. Subsequent efforts spearheaded by advocacy groups such as the National Eczema Association included the production of guidance documents for industry1 and presentations directly to the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee meeting punctuated by powerful patient testimonials.2

Serendipitously, AD, a disease that presents by kindergarten in up to 90% of affected individuals, also has caught the eye of the pharmaceutical industry. Remarkable advances in the understanding of AD inflammation have led to an explosion of new therapeutic targets of interest. By way of context, between the introduction of topical calcineurin inhibitors in 2001 and the FDA approval of dupilumab and crisaborole in 2017, there were precisely zero new molecules approved for the treatment of AD. Viewed through another lens, prior to 2017, the only FDA-approved systemic medication for AD was prednisone, a drug most AD experts would list as the least appropriate choice for treatment of this condition.

Fast-forward to 2020 and we have a plethora of new possibilities. The National Eczema Association’s research web page (https://nationaleczema.org/research/eczema-treatment-research/) reveals no fewer than 24 systemic agents in phase 2 development or beyond, including selective IL-13 inhibitors such as tralokinumab and lebrikizumab; Janus kinase inhibitors such as baricitinib3; and novel targets such as histamine 4 (ZPL-3893787), IL-31 (nemolizumab), and thymic stromal lymphopoietin. This list does not even include other biologics being repurposed for AD (eg, omalizumab4) or a host of exciting new topical agents (eg, tapinarof).



This confluence of better science, powerful advocacy, and enlightened self-interest has been revolutionary. It is most evident when parents/guardians—many of whom had long ago given up on new therapies for themselves—are gobsmacked by the new therapeutic landscape outlined for their children. Parents/guardians realize their children need not struggle as they may have themselves. The impact on quality of life has long been known, but several recent publications have brought it into finer relief. Drucker et al5 highlighted the overall burden of disease, and several subsequent papers have focused specifically on affective impacts including increased risk for depression, suicidal ideation, and suicide.6,7 In this issue of Cutis, Tracy et al8 provide an update on pediatric AD with an emphasis on comorbidities, quality of life, and evolving practices and therapies.

Better science, better drugs, better advocacy, better outcomes—it has not been a straight line, but it has indisputably been a forward-marching one. It is a new day, indeed.

References
  1. Siegfried EC, Jaworski JC, Eichenfield LF, et al. Developing drugs for the treatment of atopic dermatitis in children (≥3 months to <18 years of age): draft guidance for industry [published online March 30, 2018]. Pediatr Dermatol. 2018; May 35:303-322.
  2. Pediatric trials for AD systemic treatments. Dermatology Times. May 21, 2015. https://www.dermatologytimes.com/view/pediatric-trials-ad-systemic-treatments. Accessed August 11, 2020.
  3. Solimani F, Meier K, Ghoreschi K. Emerging topical and systemic JAK inhibitors in dermatology. Front Immunol. 2019;10:2847.
  4. Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized controlled trial. JAMA Pediatr. 2019;174:29-37.
  5. Drucker AM, Wang AR, Li W-Q, et al. The burden of atopic dermatitis: summary of a report for the National Eczema Association [published online September 8, 2016]. J Invest Dermatol. 2017;137:26-30.
  6. Sandhu JK, Wu KK, Bui T-L, et al. Association between atopic dermatitis and suicidality: a systematic review and meta-analysis. JAMA Dermatol. 2019;155:178-187.
  7. Patel KR, Immaneni S, Singam V, et al. Association between atopic dermatitis, depression, and suicidal ideation: a systematic review and meta-analysis [published online October 23, 2018]. J Am Acad Dermatol. 2019;80:402-410.
  8. Tracy A, Bhatti S, Eichenfield LF. Update on pediatric atopic dermatitis. Cutis. 2020;106:143-146.
References
  1. Siegfried EC, Jaworski JC, Eichenfield LF, et al. Developing drugs for the treatment of atopic dermatitis in children (≥3 months to <18 years of age): draft guidance for industry [published online March 30, 2018]. Pediatr Dermatol. 2018; May 35:303-322.
  2. Pediatric trials for AD systemic treatments. Dermatology Times. May 21, 2015. https://www.dermatologytimes.com/view/pediatric-trials-ad-systemic-treatments. Accessed August 11, 2020.
  3. Solimani F, Meier K, Ghoreschi K. Emerging topical and systemic JAK inhibitors in dermatology. Front Immunol. 2019;10:2847.
  4. Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized controlled trial. JAMA Pediatr. 2019;174:29-37.
  5. Drucker AM, Wang AR, Li W-Q, et al. The burden of atopic dermatitis: summary of a report for the National Eczema Association [published online September 8, 2016]. J Invest Dermatol. 2017;137:26-30.
  6. Sandhu JK, Wu KK, Bui T-L, et al. Association between atopic dermatitis and suicidality: a systematic review and meta-analysis. JAMA Dermatol. 2019;155:178-187.
  7. Patel KR, Immaneni S, Singam V, et al. Association between atopic dermatitis, depression, and suicidal ideation: a systematic review and meta-analysis [published online October 23, 2018]. J Am Acad Dermatol. 2019;80:402-410.
  8. Tracy A, Bhatti S, Eichenfield LF. Update on pediatric atopic dermatitis. Cutis. 2020;106:143-146.
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Lifting the restrictions on mifepristone during COVID-19: A step in the right direction

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Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

 

 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

 

 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

  • Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
  • Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
  • Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.
References
  1. American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
  2. Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170. 
  3. Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
  4. Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
  5. American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
  6. US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
  7. US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
  8. American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
  9. US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
  10. US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
  11. Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.
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Author and Disclosure Information

Dr. Wallace is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center, Boston, Massachusetts.

Dr. Jorgensen is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center.

Dr. Evans is Assistant Professor, Tufts University School of Medicine, and Associate Program Director, Department of Obstetrics and Gynecology, Tufts Medical Center.

The authors report no financial relationships relevant to this article.

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Dr. Wallace is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center, Boston, Massachusetts.

Dr. Jorgensen is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center.

Dr. Evans is Assistant Professor, Tufts University School of Medicine, and Associate Program Director, Department of Obstetrics and Gynecology, Tufts Medical Center.

The authors report no financial relationships relevant to this article.

Author and Disclosure Information

Dr. Wallace is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center, Boston, Massachusetts.

Dr. Jorgensen is a Resident, Department of Obstetrics and Gynecology, Tufts Medical Center.

Dr. Evans is Assistant Professor, Tufts University School of Medicine, and Associate Program Director, Department of Obstetrics and Gynecology, Tufts Medical Center.

The authors report no financial relationships relevant to this article.

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Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

 

 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

 

 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

  • Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
  • Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
  • Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.

Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

 

 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

 

 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

  • Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
  • Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
  • Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.
References
  1. American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
  2. Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170. 
  3. Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
  4. Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
  5. American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
  6. US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
  7. US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
  8. American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
  9. US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
  10. US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
  11. Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.
References
  1. American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
  2. Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170. 
  3. Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
  4. Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
  5. American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
  6. US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
  7. US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
  8. American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
  9. US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
  10. US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
  11. Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.
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OBG Manag. December 2020;32(12):13-14, 23, 38. Published online first September 10, 2020 | doi: 10.12788/obgm.0034
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It's time to change when BP meds are taken

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In this issue of JFP, there is an extraordinarily valuable PURL (Priority Updates from the Research Literature) for you. PURLs® are written by academic family physicians who comb through volumes of research to identify and then summarize for JFP important studies we believe should change your practice. After reading a PURL, you may find that you have already implemented this new evidence into your practice. In that case, the PURL confirms that you are doing the right thing.

We should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce CV morbidity and mortality?

Here is the good news from this month’s PURL: Having patients take their blood pressure (BP) medication in the evening, rather than in the morning, leads not only to better BP control but also to a reduction in cardiovascular events.1 How large is this effect? This simple intervention nearly cut in half the number of major cardiovascular events—including myocardial infarction, stroke, and congestive heart failure—and the risk for death from a cardiovascular event was reduced 56%. The number needed to treat to prevent 1 major cardiovascular event over the course of 6.3 years was 20. That means this intervention is more powerful than taking a statin!

The investigators, who call this intervention “chronotherapy” since it takes into account the body’s circadian rhythms, have been studying the effect of this simple intervention for many years, and this large randomized trial provides very strong evidence that it’s effective. Despite the excellent trial design and execution, some cardiovascular researchers have questioned the integrity of the trial and believe patients should continue to take their antihypertensives in the morning.2 The main investigator of the study, however, has provided a very strong rebuttal in print.3

I am delighted to see the positive results of this definitive trial of chronotherapy for hypertension. When these investigators published their first randomized trial of chronotherapy in 2010,4 which demonstrated a significant BP reduction with evening dosing of antihypertensives, I began telling all of my patients to take at least 1 of their antihypertensive meds in the evening. Maybe I was jumping the gun at that time, but we should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce cardiovascular morbidity and mortality?

References

1. Hermida RC, Crespo JJ, Domínguez-Sardiña M, et al. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial [published online ahead of print October 22, 2019]. Eur Heart J. 2019;ehz754. doi:10.1093/eurheartj/ehz754

2. Kreutz R, Kjeldsen SE, Burnier M, et al. Blood pressure medication should not be routinely dosed at bedtime. We must disregard the data from the HYGIA project [editorial]. Blood Press. 2020;29:135-136.

3. Crespo JJ, Domínguez-Sardiña M, Otero A, et. al. Bedtime hypertension chronotherapy best reduces cardiovascular disease risk as corroborated by the Hygia Chronotherapy Trial. Rebuttal to European Society of Hypertension officials. Chronobiol Int. 2020;37:771-780.

4. Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010;27:1629-1651.

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In this issue of JFP, there is an extraordinarily valuable PURL (Priority Updates from the Research Literature) for you. PURLs® are written by academic family physicians who comb through volumes of research to identify and then summarize for JFP important studies we believe should change your practice. After reading a PURL, you may find that you have already implemented this new evidence into your practice. In that case, the PURL confirms that you are doing the right thing.

We should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce CV morbidity and mortality?

Here is the good news from this month’s PURL: Having patients take their blood pressure (BP) medication in the evening, rather than in the morning, leads not only to better BP control but also to a reduction in cardiovascular events.1 How large is this effect? This simple intervention nearly cut in half the number of major cardiovascular events—including myocardial infarction, stroke, and congestive heart failure—and the risk for death from a cardiovascular event was reduced 56%. The number needed to treat to prevent 1 major cardiovascular event over the course of 6.3 years was 20. That means this intervention is more powerful than taking a statin!

The investigators, who call this intervention “chronotherapy” since it takes into account the body’s circadian rhythms, have been studying the effect of this simple intervention for many years, and this large randomized trial provides very strong evidence that it’s effective. Despite the excellent trial design and execution, some cardiovascular researchers have questioned the integrity of the trial and believe patients should continue to take their antihypertensives in the morning.2 The main investigator of the study, however, has provided a very strong rebuttal in print.3

I am delighted to see the positive results of this definitive trial of chronotherapy for hypertension. When these investigators published their first randomized trial of chronotherapy in 2010,4 which demonstrated a significant BP reduction with evening dosing of antihypertensives, I began telling all of my patients to take at least 1 of their antihypertensive meds in the evening. Maybe I was jumping the gun at that time, but we should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce cardiovascular morbidity and mortality?

In this issue of JFP, there is an extraordinarily valuable PURL (Priority Updates from the Research Literature) for you. PURLs® are written by academic family physicians who comb through volumes of research to identify and then summarize for JFP important studies we believe should change your practice. After reading a PURL, you may find that you have already implemented this new evidence into your practice. In that case, the PURL confirms that you are doing the right thing.

We should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce CV morbidity and mortality?

Here is the good news from this month’s PURL: Having patients take their blood pressure (BP) medication in the evening, rather than in the morning, leads not only to better BP control but also to a reduction in cardiovascular events.1 How large is this effect? This simple intervention nearly cut in half the number of major cardiovascular events—including myocardial infarction, stroke, and congestive heart failure—and the risk for death from a cardiovascular event was reduced 56%. The number needed to treat to prevent 1 major cardiovascular event over the course of 6.3 years was 20. That means this intervention is more powerful than taking a statin!

The investigators, who call this intervention “chronotherapy” since it takes into account the body’s circadian rhythms, have been studying the effect of this simple intervention for many years, and this large randomized trial provides very strong evidence that it’s effective. Despite the excellent trial design and execution, some cardiovascular researchers have questioned the integrity of the trial and believe patients should continue to take their antihypertensives in the morning.2 The main investigator of the study, however, has provided a very strong rebuttal in print.3

I am delighted to see the positive results of this definitive trial of chronotherapy for hypertension. When these investigators published their first randomized trial of chronotherapy in 2010,4 which demonstrated a significant BP reduction with evening dosing of antihypertensives, I began telling all of my patients to take at least 1 of their antihypertensive meds in the evening. Maybe I was jumping the gun at that time, but we should all tell our patients to take their BP medication in the evening from now on. What could be an easier way to reduce cardiovascular morbidity and mortality?

References

1. Hermida RC, Crespo JJ, Domínguez-Sardiña M, et al. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial [published online ahead of print October 22, 2019]. Eur Heart J. 2019;ehz754. doi:10.1093/eurheartj/ehz754

2. Kreutz R, Kjeldsen SE, Burnier M, et al. Blood pressure medication should not be routinely dosed at bedtime. We must disregard the data from the HYGIA project [editorial]. Blood Press. 2020;29:135-136.

3. Crespo JJ, Domínguez-Sardiña M, Otero A, et. al. Bedtime hypertension chronotherapy best reduces cardiovascular disease risk as corroborated by the Hygia Chronotherapy Trial. Rebuttal to European Society of Hypertension officials. Chronobiol Int. 2020;37:771-780.

4. Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010;27:1629-1651.

References

1. Hermida RC, Crespo JJ, Domínguez-Sardiña M, et al. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial [published online ahead of print October 22, 2019]. Eur Heart J. 2019;ehz754. doi:10.1093/eurheartj/ehz754

2. Kreutz R, Kjeldsen SE, Burnier M, et al. Blood pressure medication should not be routinely dosed at bedtime. We must disregard the data from the HYGIA project [editorial]. Blood Press. 2020;29:135-136.

3. Crespo JJ, Domínguez-Sardiña M, Otero A, et. al. Bedtime hypertension chronotherapy best reduces cardiovascular disease risk as corroborated by the Hygia Chronotherapy Trial. Rebuttal to European Society of Hypertension officials. Chronobiol Int. 2020;37:771-780.

4. Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010;27:1629-1651.

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A woman with an asymptomatic eruption on her palms after exposure to water

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Aquagenic wrinkling of the palms (AWP) is a condition characterized by excessive wrinkling and sudden appearance or aggravation of white papules and plaques localized to the palms upon exposure to water. This eruption can be accompanied by a mild burning or tingling sensation, which will subside with the rest of the symptoms in minutes to hours after drying.1

AWP is most frequently associated with cystic fibrosis (CF).2 It can be observed in up to 80% of CF patients and is considered a clinical sign of the disease. AWP can be present in CF carriers to a lesser extent,2,4 and has also been associated with focal hyperhidrosis, atopic dermatitis, Raynaud phenomenon, and COX-2 inhibitor use.5

While a definitive cause is unknown, it is thought that AWP is caused by dysregulation of sweat glands in the palms through increased expression of aquaporin, a protein crucial in the transport of water between cells.3

AWP is quite rare and benign in nature. However, because of its strong association with CF, genetic screening should be considered in asymptomatic patients. Our patient had been screened in the past and is not a CF carrier. Often, the itching or burning associated with CF is mild and easily controlled. The patient was placed on low dose isotretinoin for treatment of her acne. Interestingly, the patient claimed her eruption no longer appeared after starting isotretinoin therapy. To our knowledge, this is the first reported case of AWP resolving with isotretinoin use.

This case and photo were submitted by Mr. Birk, University of Texas, Austin, Texas; and Dr. Mamelak, Sanova Dermatology, in Austin. Donna Bilu Martin, MD, edited the column.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at MDedge.com/Dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Katz M, Ramot Y. CMAJ. 2015 Dec 8;187(18):E515.

2. Tolland JP et al. Dermatology. 2010;221(4):326-30.

3. Kabashima K et al. J Am Acad Dermatol. 2008 Aug;59(2 Suppl 1):S28-32.

4. Gild R et al. Br J Dermatol. 2010 Nov;163(5):1082-4.

5. Glatz M and Muellegger RR. BMJ Case Rep. 2014. doi: 10.1136/bcr-2014-203929.

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Aquagenic wrinkling of the palms (AWP) is a condition characterized by excessive wrinkling and sudden appearance or aggravation of white papules and plaques localized to the palms upon exposure to water. This eruption can be accompanied by a mild burning or tingling sensation, which will subside with the rest of the symptoms in minutes to hours after drying.1

AWP is most frequently associated with cystic fibrosis (CF).2 It can be observed in up to 80% of CF patients and is considered a clinical sign of the disease. AWP can be present in CF carriers to a lesser extent,2,4 and has also been associated with focal hyperhidrosis, atopic dermatitis, Raynaud phenomenon, and COX-2 inhibitor use.5

While a definitive cause is unknown, it is thought that AWP is caused by dysregulation of sweat glands in the palms through increased expression of aquaporin, a protein crucial in the transport of water between cells.3

AWP is quite rare and benign in nature. However, because of its strong association with CF, genetic screening should be considered in asymptomatic patients. Our patient had been screened in the past and is not a CF carrier. Often, the itching or burning associated with CF is mild and easily controlled. The patient was placed on low dose isotretinoin for treatment of her acne. Interestingly, the patient claimed her eruption no longer appeared after starting isotretinoin therapy. To our knowledge, this is the first reported case of AWP resolving with isotretinoin use.

This case and photo were submitted by Mr. Birk, University of Texas, Austin, Texas; and Dr. Mamelak, Sanova Dermatology, in Austin. Donna Bilu Martin, MD, edited the column.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at MDedge.com/Dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Katz M, Ramot Y. CMAJ. 2015 Dec 8;187(18):E515.

2. Tolland JP et al. Dermatology. 2010;221(4):326-30.

3. Kabashima K et al. J Am Acad Dermatol. 2008 Aug;59(2 Suppl 1):S28-32.

4. Gild R et al. Br J Dermatol. 2010 Nov;163(5):1082-4.

5. Glatz M and Muellegger RR. BMJ Case Rep. 2014. doi: 10.1136/bcr-2014-203929.

Aquagenic wrinkling of the palms (AWP) is a condition characterized by excessive wrinkling and sudden appearance or aggravation of white papules and plaques localized to the palms upon exposure to water. This eruption can be accompanied by a mild burning or tingling sensation, which will subside with the rest of the symptoms in minutes to hours after drying.1

AWP is most frequently associated with cystic fibrosis (CF).2 It can be observed in up to 80% of CF patients and is considered a clinical sign of the disease. AWP can be present in CF carriers to a lesser extent,2,4 and has also been associated with focal hyperhidrosis, atopic dermatitis, Raynaud phenomenon, and COX-2 inhibitor use.5

While a definitive cause is unknown, it is thought that AWP is caused by dysregulation of sweat glands in the palms through increased expression of aquaporin, a protein crucial in the transport of water between cells.3

AWP is quite rare and benign in nature. However, because of its strong association with CF, genetic screening should be considered in asymptomatic patients. Our patient had been screened in the past and is not a CF carrier. Often, the itching or burning associated with CF is mild and easily controlled. The patient was placed on low dose isotretinoin for treatment of her acne. Interestingly, the patient claimed her eruption no longer appeared after starting isotretinoin therapy. To our knowledge, this is the first reported case of AWP resolving with isotretinoin use.

This case and photo were submitted by Mr. Birk, University of Texas, Austin, Texas; and Dr. Mamelak, Sanova Dermatology, in Austin. Donna Bilu Martin, MD, edited the column.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at MDedge.com/Dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Katz M, Ramot Y. CMAJ. 2015 Dec 8;187(18):E515.

2. Tolland JP et al. Dermatology. 2010;221(4):326-30.

3. Kabashima K et al. J Am Acad Dermatol. 2008 Aug;59(2 Suppl 1):S28-32.

4. Gild R et al. Br J Dermatol. 2010 Nov;163(5):1082-4.

5. Glatz M and Muellegger RR. BMJ Case Rep. 2014. doi: 10.1136/bcr-2014-203929.

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A 28-year-old female with no significant medical history presented for the evaluation and treatment of persistent acne. Upon questioning, the patient noted an asymptomatic eruption on her palms consistently induced after exposure to water. The patient denied any significant pain associated with the eruption and had no history of hyperhidrosis. Her only medication was an oral contraceptive, and there were no known drug allergies. She denied any family history of similar complaints. On exam, white, slightly translucent papules on the palms were noted within 10 min of water exposure. The palmar skin became edematous and excessive wrinkling was observed. The eruption resolved about 10 min after drying her hands with no significant sequelae.

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Five reasons why medical meetings will never be the same

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In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.

Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.

In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.

And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.

Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
 

Reshaping the medical meeting

Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.

This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.

Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.

Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.

Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.

Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.

I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.

Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.

We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.

H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.

This article first appeared on Medscape.com.

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In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.

Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.

In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.

And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.

Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
 

Reshaping the medical meeting

Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.

This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.

Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.

Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.

Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.

Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.

I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.

Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.

We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.

H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.

This article first appeared on Medscape.com.

 

In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.

Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.

In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.

And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.

Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
 

Reshaping the medical meeting

Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.

This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.

Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.

Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.

Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.

Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.

I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.

Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.

We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.

H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.

This article first appeared on Medscape.com.

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We are all in this together: Lessons learned on a COVID-19 unit

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Like most family medicine residencies, our teaching nursing home was struck with a COVID-19 outbreak. Within 10 days, I was the sole physician responsible for 15 patients with varying degrees of illness, quarantined behind the fire doors of a wing of a Memory Support Unit. My daily work there over the course of the next month prompted me to reflect on some of the core principles of family medicine, and health care, that are vital to effective patient care during a pandemic. My experience provided the following reminders:

Work as a team. Gowned, gloved, and masked behind the fire doors, our world shrank to our patients and a 4-person team comprised of a nurse, 2 nursing assistants, and me. For the first time in the 10+ years I’ve worked at that facility, I actually asked for and memorized the names of everyone I was working with that day. Without an intercom or other telecommunications system, it became important for me to be able to call for my team members by name for immediate help. We had to depend on one another to make sure all patients were hydrated and fed, to avert falls whenever possible, to intervene early when dementia-­associated behaviors were escalating, and to recognize when patients were crashing.

I began asking for the names of everyone I was working with that day and I observed, first-hand, the great finesse that nurses display in their efforts to de-escalate disruptive behaviors.

We also had to depend on each other to ensure that our personal protective equipment remained properly placed, to combat the psychological sense of isolation that quarantine environments engender, and to placate a gnawing undercurrent of unease while working around a potentially deadly pathogen.

 

Develop clinical routines. Having listened to other medical directors whose nursing homes were affected by the pandemic earlier than we were, and hearing about potentially avoidable complications, we developed clinical routines. This began with identifying any patients with diabetes whose poor appetites while acutely ill could send them into hypoglycemia. We devised a daily clinical report sheet that included vital signs, date of positive COVID-19 test, global clinical status, and advance directives. Unlike the usual mode of working almost in parallel, I began my workday with a “sign-out” from the nurse, then started examining each patient.

Under the strain of this unusual environment and novel circumstances, we communicated more and more often. This allowed us to quickly recognize and communicate emerging changes in the clinical status of a patient by sharing our observations of subtle, nonspecific “sub-threshold” indicators.

Clarify the goals of care. Since most of the patients in the COVID-19 unit were under the long-term care of other attending physicians, it was important for me to understand the wishes of the patient or surrogate decision maker, should life-threatening complications occur. While all affected patients were long-term residents of a memory support unit, some had full-code advance directives. I quickly realized that what was first necessary was to develop rapport and trust with the families who didn’t know me, then discuss goals of care, and finally assure that the advance directives were in congruence with their stated goals. What helped families gain trust in me was knowing that I was seeing their loved one daily, that I was committed to helping the patient survive this infection, and that I was willing to come back to the facility if a crisis occurred—even at night, if necessary.

Appreciate the daily work of team members. One of my greatest worries was dehydration. When elders were acutely ill and eating and drinking poorly, I would assist with feeding and offering liquids. I quickly came to appreciate how complex and subtle this seemingly mundane task can be. Learning the proper pace and portion size, even choosing the right conversation topic and tone, could make the difference between a patient “shutting down” and refusing all nourishment and successfully drinking a 360-cc cup of a high-nutrient shake.

Continue to: In the disrupted routines...

 

 

In the disrupted routines and altered physical environments of the COVID-19 unit, the psychological and behavioral complications of dementia intensified for some patients. I observed first-hand the great patience, kindness, and finesse that nurses and nursing assistants display in their efforts to de-escalate and prevent disruptive behaviors.

Empathize with (and appreciate) families. Families tearfully reminded me that they had been suffering from the absence of contact with their loved ones for months; COVID-19 added to that trauma for many of them. They talked about the missed graduations, birthdays, and other precious times together that were lost because of the quarantine.

Families also prevented me from making mistakes. When I ordered nitrofurantoin for a patient with a urinary tract infection, her son called me and respectfully requested I “just check and make sure” it would not cause a problem, given her G6PD deficiency. He prevented me from prescribing an antibiotic contraindicated in that condition.

Bring forward the lessons learned. The COVID-19 outbreak has passed through our nursing home—at least for now. I perceive a subtle shift in how we continue to interact with one another. Behind the masks, we make a little more eye contact; we more often address each other by name; and we acknowledge a greater mutual respect.

The shared experience of COVID-19 has brought us all a little closer together, and in the end, our patients have benefitted.

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Cleveland Clinic Family Medicine Residency, Lakewood, OH

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Like most family medicine residencies, our teaching nursing home was struck with a COVID-19 outbreak. Within 10 days, I was the sole physician responsible for 15 patients with varying degrees of illness, quarantined behind the fire doors of a wing of a Memory Support Unit. My daily work there over the course of the next month prompted me to reflect on some of the core principles of family medicine, and health care, that are vital to effective patient care during a pandemic. My experience provided the following reminders:

Work as a team. Gowned, gloved, and masked behind the fire doors, our world shrank to our patients and a 4-person team comprised of a nurse, 2 nursing assistants, and me. For the first time in the 10+ years I’ve worked at that facility, I actually asked for and memorized the names of everyone I was working with that day. Without an intercom or other telecommunications system, it became important for me to be able to call for my team members by name for immediate help. We had to depend on one another to make sure all patients were hydrated and fed, to avert falls whenever possible, to intervene early when dementia-­associated behaviors were escalating, and to recognize when patients were crashing.

I began asking for the names of everyone I was working with that day and I observed, first-hand, the great finesse that nurses display in their efforts to de-escalate disruptive behaviors.

We also had to depend on each other to ensure that our personal protective equipment remained properly placed, to combat the psychological sense of isolation that quarantine environments engender, and to placate a gnawing undercurrent of unease while working around a potentially deadly pathogen.

 

Develop clinical routines. Having listened to other medical directors whose nursing homes were affected by the pandemic earlier than we were, and hearing about potentially avoidable complications, we developed clinical routines. This began with identifying any patients with diabetes whose poor appetites while acutely ill could send them into hypoglycemia. We devised a daily clinical report sheet that included vital signs, date of positive COVID-19 test, global clinical status, and advance directives. Unlike the usual mode of working almost in parallel, I began my workday with a “sign-out” from the nurse, then started examining each patient.

Under the strain of this unusual environment and novel circumstances, we communicated more and more often. This allowed us to quickly recognize and communicate emerging changes in the clinical status of a patient by sharing our observations of subtle, nonspecific “sub-threshold” indicators.

Clarify the goals of care. Since most of the patients in the COVID-19 unit were under the long-term care of other attending physicians, it was important for me to understand the wishes of the patient or surrogate decision maker, should life-threatening complications occur. While all affected patients were long-term residents of a memory support unit, some had full-code advance directives. I quickly realized that what was first necessary was to develop rapport and trust with the families who didn’t know me, then discuss goals of care, and finally assure that the advance directives were in congruence with their stated goals. What helped families gain trust in me was knowing that I was seeing their loved one daily, that I was committed to helping the patient survive this infection, and that I was willing to come back to the facility if a crisis occurred—even at night, if necessary.

Appreciate the daily work of team members. One of my greatest worries was dehydration. When elders were acutely ill and eating and drinking poorly, I would assist with feeding and offering liquids. I quickly came to appreciate how complex and subtle this seemingly mundane task can be. Learning the proper pace and portion size, even choosing the right conversation topic and tone, could make the difference between a patient “shutting down” and refusing all nourishment and successfully drinking a 360-cc cup of a high-nutrient shake.

Continue to: In the disrupted routines...

 

 

In the disrupted routines and altered physical environments of the COVID-19 unit, the psychological and behavioral complications of dementia intensified for some patients. I observed first-hand the great patience, kindness, and finesse that nurses and nursing assistants display in their efforts to de-escalate and prevent disruptive behaviors.

Empathize with (and appreciate) families. Families tearfully reminded me that they had been suffering from the absence of contact with their loved ones for months; COVID-19 added to that trauma for many of them. They talked about the missed graduations, birthdays, and other precious times together that were lost because of the quarantine.

Families also prevented me from making mistakes. When I ordered nitrofurantoin for a patient with a urinary tract infection, her son called me and respectfully requested I “just check and make sure” it would not cause a problem, given her G6PD deficiency. He prevented me from prescribing an antibiotic contraindicated in that condition.

Bring forward the lessons learned. The COVID-19 outbreak has passed through our nursing home—at least for now. I perceive a subtle shift in how we continue to interact with one another. Behind the masks, we make a little more eye contact; we more often address each other by name; and we acknowledge a greater mutual respect.

The shared experience of COVID-19 has brought us all a little closer together, and in the end, our patients have benefitted.

Like most family medicine residencies, our teaching nursing home was struck with a COVID-19 outbreak. Within 10 days, I was the sole physician responsible for 15 patients with varying degrees of illness, quarantined behind the fire doors of a wing of a Memory Support Unit. My daily work there over the course of the next month prompted me to reflect on some of the core principles of family medicine, and health care, that are vital to effective patient care during a pandemic. My experience provided the following reminders:

Work as a team. Gowned, gloved, and masked behind the fire doors, our world shrank to our patients and a 4-person team comprised of a nurse, 2 nursing assistants, and me. For the first time in the 10+ years I’ve worked at that facility, I actually asked for and memorized the names of everyone I was working with that day. Without an intercom or other telecommunications system, it became important for me to be able to call for my team members by name for immediate help. We had to depend on one another to make sure all patients were hydrated and fed, to avert falls whenever possible, to intervene early when dementia-­associated behaviors were escalating, and to recognize when patients were crashing.

I began asking for the names of everyone I was working with that day and I observed, first-hand, the great finesse that nurses display in their efforts to de-escalate disruptive behaviors.

We also had to depend on each other to ensure that our personal protective equipment remained properly placed, to combat the psychological sense of isolation that quarantine environments engender, and to placate a gnawing undercurrent of unease while working around a potentially deadly pathogen.

 

Develop clinical routines. Having listened to other medical directors whose nursing homes were affected by the pandemic earlier than we were, and hearing about potentially avoidable complications, we developed clinical routines. This began with identifying any patients with diabetes whose poor appetites while acutely ill could send them into hypoglycemia. We devised a daily clinical report sheet that included vital signs, date of positive COVID-19 test, global clinical status, and advance directives. Unlike the usual mode of working almost in parallel, I began my workday with a “sign-out” from the nurse, then started examining each patient.

Under the strain of this unusual environment and novel circumstances, we communicated more and more often. This allowed us to quickly recognize and communicate emerging changes in the clinical status of a patient by sharing our observations of subtle, nonspecific “sub-threshold” indicators.

Clarify the goals of care. Since most of the patients in the COVID-19 unit were under the long-term care of other attending physicians, it was important for me to understand the wishes of the patient or surrogate decision maker, should life-threatening complications occur. While all affected patients were long-term residents of a memory support unit, some had full-code advance directives. I quickly realized that what was first necessary was to develop rapport and trust with the families who didn’t know me, then discuss goals of care, and finally assure that the advance directives were in congruence with their stated goals. What helped families gain trust in me was knowing that I was seeing their loved one daily, that I was committed to helping the patient survive this infection, and that I was willing to come back to the facility if a crisis occurred—even at night, if necessary.

Appreciate the daily work of team members. One of my greatest worries was dehydration. When elders were acutely ill and eating and drinking poorly, I would assist with feeding and offering liquids. I quickly came to appreciate how complex and subtle this seemingly mundane task can be. Learning the proper pace and portion size, even choosing the right conversation topic and tone, could make the difference between a patient “shutting down” and refusing all nourishment and successfully drinking a 360-cc cup of a high-nutrient shake.

Continue to: In the disrupted routines...

 

 

In the disrupted routines and altered physical environments of the COVID-19 unit, the psychological and behavioral complications of dementia intensified for some patients. I observed first-hand the great patience, kindness, and finesse that nurses and nursing assistants display in their efforts to de-escalate and prevent disruptive behaviors.

Empathize with (and appreciate) families. Families tearfully reminded me that they had been suffering from the absence of contact with their loved ones for months; COVID-19 added to that trauma for many of them. They talked about the missed graduations, birthdays, and other precious times together that were lost because of the quarantine.

Families also prevented me from making mistakes. When I ordered nitrofurantoin for a patient with a urinary tract infection, her son called me and respectfully requested I “just check and make sure” it would not cause a problem, given her G6PD deficiency. He prevented me from prescribing an antibiotic contraindicated in that condition.

Bring forward the lessons learned. The COVID-19 outbreak has passed through our nursing home—at least for now. I perceive a subtle shift in how we continue to interact with one another. Behind the masks, we make a little more eye contact; we more often address each other by name; and we acknowledge a greater mutual respect.

The shared experience of COVID-19 has brought us all a little closer together, and in the end, our patients have benefitted.

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