Mixed Topics

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

A new multicenter trial has yielded conflicting results regarding intranasal insulin’s ability to deliver cognitive and functional benefit for patients with mild cognitive impairment (MCI) and Alzheimer’s disease. The randomized trial of nearly 300 patients showed that, although one insulin administration device produced marked benefit in terms of change in mean score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12) over 12 months, reliability was inconsistent. A second device, used on the majority of patients in the study’s intention-to-treat population, showed no difference in these measures between patients who did and those who did not receive intranasal insulin.

“The primary analysis of the study showed no benefit of intranasal insulin on any measures of cognition or cerebrospinal fluid Alzheimer’s disease biomarkers when using the new device,” said principal investigator Suzanne Craft, PhD.

“But when we looked at our planned secondary analysis with the original device – which has been successful in previous studies – we saw quite a different picture,” added Dr. Craft, director of the Alzheimer’s Disease Research Center at Wake Forest University, Winston-Salem, N.C.

“We found a pronounced benefit with that device, such that after 18 months of administration, participants who had been receiving insulin from the beginning of the study had a large and clinically significant advantage in the primary outcome measure.”

Dr. Craft described the findings as complex. “The primary results were negative,” she added. “But the secondary results replicated those of several earlier studies when we used the same device that was used in those.”

The study was published online June 22 in JAMA Neurology.

Important for brain function

Insulin has been shown to play several important roles in brain function. The hormone is associated with a variety of cognitive functions, including memory. Through its association with vasoreactivity, lipid metabolism, and inflammation, insulin also plays an important role in vascular function.

“In the normal brain in healthy individuals, insulin is very important for synaptic function and viability. Insulin also promotes dendritic growth and facilitates synaptic health. Through this role, it plays an important part in memory,” said Dr. Craft. Given these connections, it is not surprising that reduced insulin levels or activity in brain and cerebrospinal fluid have been documented in some, but not all, studies of Alzheimer’s disease. Markers of insulin resistance also have been detected in both neuronally derived exosomes and brain tissue from adults with Alzheimer’s disease.

In light of the several important roles that insulin plays in the brain – coupled with the evidence connecting dysregulation of brain insulin and AD pathology – restoring brain insulin function may offer therapeutic benefit for adults suffering either Alzheimer’s disease or MCI. “There are a number of ways to do this,” said Dr. Craft. “But one of the approaches that we’ve focused on is providing insulin directly to the brain through intranasal administration. “By doing this, you circumvent potential issues if you administered insulin systemically.”

Previous research has shown that through this mode of administration, insulin can bypass the blood-brain barrier and reach the brain through olfactory and trigeminal perivascular channels, with little effect on peripheral insulin or blood glucose levels.

As previously reported, an earlier pilot study, also conducted by Dr. Craft and her team, showed that 4 months of daily intranasal administration of 20 IU or 40 IU of insulin preserved cognitive performance in individuals with Alzheimer’s disease or MCI.

Deeper dive

In the current investigation, the researchers wanted to broaden these findings in a larger, longer, randomized double-blinded clinical trial. The investigators assessed the efficacy of intranasal insulin on cognition, function, and biomarkers of Alzheimer’s disease, as well as the safety and feasibility of the delivery method. The multicenter trial was conducted from 2014 to 2018 and included 27 sites.

Study participants were between the ages of 55 and 85 years and had been diagnosed with amnestic MCI or Alzheimer’s disease on the basis of National Institute on Aging–Alzheimer Association criteria, a score of 20 or higher on the Mini–Mental State Examination, a clinical dementia rating of 0.5 or 1.0, or a delayed logical memory score within a specified range.

In total, 289 participants were randomly assigned to receive 40 IU of insulin or placebo for 12 months, followed by a 6-month open-label extension phase. The first 49 participants (32 men; mean age, 71.9 years) underwent insulin administration with the same device the investigators used in previous trials.

Of these, 45 completed the blinded phase, and 42 completed the open-label extension. When this device, which uses an electronic nebulizer-like delivery system, proved unreliable, the researchers switched to a second device, which uses a liquid hydrofluoroalkane propellant to deliver a metered dose of insulin through a nose tip without electronic assistance. Device 2 was used for the remaining 240 participants (123 men; mean age, 70.8 years). These patients became the study’s primary intention-to-treat population.

The study’s primary outcome was the mean change in score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12), which was evaluated at 3-month intervals.

Secondary clinical outcomes were assessed at 6-month intervals. These included the mean change in scores for the Alzheimer Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment and the Clinical Dementia Rating Scale Sum of Boxes.

Safety and adherence were also assessed during each study visit. Physical and neurologic examinations were performed at baseline and at months 6, 12, and 18.

Of the primary intention-to-treat population of 240 patients, 121 were randomly assigned to receive intranasal insulin. The remaining 119 received placebo and served as controls. The two groups were demographically comparable.

Better cognitive performance

A total of 215 participants completed the blinded phase; 198 participants completed the open-label extension. Discontinuation rates were comparable in both arms. The researchers found no differences between groups with respect to mean change in ADAS-cog-12 score from baseline to month 12 (0.0258 points; 95% confidence interval, –1.771 to 1.822 points; P = .98). The two groups also proved comparable in terms of performance on all other cognitive tests.

The open-label portion yielded similar results. Participants originally assigned to the insulin arm and their counterparts in the placebo arm did not differ with respect to mean score change on the ADAS-cog-12 test (or any other outcome) at either month 15 or 18.

Cerebrospinal fluid insulin levels were unchanged between groups, as were blood glucose and hemoglobin A1c values. Indeed, levels of A-beta42, A-beta40, total tau protein, and tau p-181 were comparable for the patients who received intranasal insulin and those who received placebo.

The most common adverse events were infections, injuries, respiratory disorders, and nervous system disorders, though these did not differ between groups. In addition, there were no differences between groups with respect to severity of adverse events; most were rated as mild.

In contrast with the intention-to-treat population, the study’s secondary analysis – using data from the original administration device – yielded markedly different results. In the blinded phase, patients who received insulin had better ADAS-cog-12 performance at 12 months (−2.81 points; 95% CI, −6.09 to 0.45 points; P = .09) and nominally significant effects at 6 months (−3.78 points; 95% CI, −6.79 to −0.78 points; P = .01).

Device type critical

These effects persisted in the open-label analyses. Patients who received intranasal insulin had superior ADAS-cog-12 scores at month 15 (−5.70 points; 95% CI, −9.62 to −1.79 points; P = .004) and month 18 (−5.78 points; 95% CI, −10.55 to −1.01 points; P = .02), compared with their counterparts who received insulin via the second device. This part of the study also showed that, although individual biomarkers did not differ significantly between the two arms, the ratios of A-beta42 to A-beta40 (P = .01) and A-beta42 to total tau (P = .03) increased with use of the first device. The number, type, and severity of adverse events were comparable between the insulin and placebo groups in this arm of the study.

The mixed results revealed by the trial demonstrate that the device used for intranasal insulin administration is paramount in determining the therapy’s potential efficacy. “Our take-home message is that the device is a very important factor for these studies and that one needs to validate their ability to effectively deliver insulin to the CNS,” said Dr. Craft.

“We were quite confident that the first device was able to do that. On the other hand, the second device has never been tested in that way, and we still don’t know whether or not that device was able to successfully deliver insulin,” she said.

The investigators recognize the need for more research in the field. Such studies, Dr. Craft noted, will utilize administration devices that have been previously verified to have the ability to deliver insulin to the central nervous system. “We’re currently testing several devices,” she noted. “We’re using a protocol where we administer insulin with the devices and then conduct a lumbar puncture about 30 minutes later to verify that it is actually raising insulin levels in the cerebrospinal fluid.”

Not a failure

Commenting on the findings, Samuel E. Gandy, MD, PhD, who was not involved in the study, said the research illustrates the challenge when a new therapy, a new delivery device, and a cohort of cognitively impaired patients collide. “The result is not quite a slam dunk but is also by no means a failure,” commented Dr. Gandy, Mount Sinai Chair in Alzheimer’s Research at Mount Sinai Medical Center, New York.

“One looks forward to future iterations of the Craft et al. approach, wherein the trialists tweak the ligand and/or the delivery schedule and/or the device and/or the disease and/or the disease stage,” Dr. Gandy added. “Another ligand, VGF, also holds promise for intranasal delivery, based on work from Steve Salton, Michelle Ehrlich, and Eric Schadt, all from Mount Sinai. Perhaps the nose knows!”

For Dr. Craft, the potential upside of intranasal insulin for these patients is significant and warrants further investigation. “I understand why people who are not familiar with prior research in this area might be skeptical of our enthusiasm, given the results in the intention-to-treat population,” she said. “But those of us who have been working along with this for a while now, we feel like we’ve got to do the next study. But we need to have a device that we know works,” Dr. Craft added.

“If this is real, then there may be a very large clinical benefit in symptomatic patients, and there’s nothing so far that has really improved symptomatic disease.”

The study was supported by the National Institute on Aging. Eli Lilly provided diluent placebo for the blinded phase and insulin for the open-label phase of the clinical trial at no cost. Dr. Craft received grants from the National Institute on Aging and nonfinancial support from Eli Lilly during the conduct of the study and personal fees from T3D Therapeutics and vTv Therapeutics outside the submitted work.

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

A new multicenter trial has yielded conflicting results regarding intranasal insulin’s ability to deliver cognitive and functional benefit for patients with mild cognitive impairment (MCI) and Alzheimer’s disease. The randomized trial of nearly 300 patients showed that, although one insulin administration device produced marked benefit in terms of change in mean score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12) over 12 months, reliability was inconsistent. A second device, used on the majority of patients in the study’s intention-to-treat population, showed no difference in these measures between patients who did and those who did not receive intranasal insulin.

“The primary analysis of the study showed no benefit of intranasal insulin on any measures of cognition or cerebrospinal fluid Alzheimer’s disease biomarkers when using the new device,” said principal investigator Suzanne Craft, PhD.

“But when we looked at our planned secondary analysis with the original device – which has been successful in previous studies – we saw quite a different picture,” added Dr. Craft, director of the Alzheimer’s Disease Research Center at Wake Forest University, Winston-Salem, N.C.

“We found a pronounced benefit with that device, such that after 18 months of administration, participants who had been receiving insulin from the beginning of the study had a large and clinically significant advantage in the primary outcome measure.”

Dr. Craft described the findings as complex. “The primary results were negative,” she added. “But the secondary results replicated those of several earlier studies when we used the same device that was used in those.”

The study was published online June 22 in JAMA Neurology.

Important for brain function

Insulin has been shown to play several important roles in brain function. The hormone is associated with a variety of cognitive functions, including memory. Through its association with vasoreactivity, lipid metabolism, and inflammation, insulin also plays an important role in vascular function.

“In the normal brain in healthy individuals, insulin is very important for synaptic function and viability. Insulin also promotes dendritic growth and facilitates synaptic health. Through this role, it plays an important part in memory,” said Dr. Craft. Given these connections, it is not surprising that reduced insulin levels or activity in brain and cerebrospinal fluid have been documented in some, but not all, studies of Alzheimer’s disease. Markers of insulin resistance also have been detected in both neuronally derived exosomes and brain tissue from adults with Alzheimer’s disease.

In light of the several important roles that insulin plays in the brain – coupled with the evidence connecting dysregulation of brain insulin and AD pathology – restoring brain insulin function may offer therapeutic benefit for adults suffering either Alzheimer’s disease or MCI. “There are a number of ways to do this,” said Dr. Craft. “But one of the approaches that we’ve focused on is providing insulin directly to the brain through intranasal administration. “By doing this, you circumvent potential issues if you administered insulin systemically.”

Previous research has shown that through this mode of administration, insulin can bypass the blood-brain barrier and reach the brain through olfactory and trigeminal perivascular channels, with little effect on peripheral insulin or blood glucose levels.

As previously reported, an earlier pilot study, also conducted by Dr. Craft and her team, showed that 4 months of daily intranasal administration of 20 IU or 40 IU of insulin preserved cognitive performance in individuals with Alzheimer’s disease or MCI.

Deeper dive

In the current investigation, the researchers wanted to broaden these findings in a larger, longer, randomized double-blinded clinical trial. The investigators assessed the efficacy of intranasal insulin on cognition, function, and biomarkers of Alzheimer’s disease, as well as the safety and feasibility of the delivery method. The multicenter trial was conducted from 2014 to 2018 and included 27 sites.

Study participants were between the ages of 55 and 85 years and had been diagnosed with amnestic MCI or Alzheimer’s disease on the basis of National Institute on Aging–Alzheimer Association criteria, a score of 20 or higher on the Mini–Mental State Examination, a clinical dementia rating of 0.5 or 1.0, or a delayed logical memory score within a specified range.

In total, 289 participants were randomly assigned to receive 40 IU of insulin or placebo for 12 months, followed by a 6-month open-label extension phase. The first 49 participants (32 men; mean age, 71.9 years) underwent insulin administration with the same device the investigators used in previous trials.

Of these, 45 completed the blinded phase, and 42 completed the open-label extension. When this device, which uses an electronic nebulizer-like delivery system, proved unreliable, the researchers switched to a second device, which uses a liquid hydrofluoroalkane propellant to deliver a metered dose of insulin through a nose tip without electronic assistance. Device 2 was used for the remaining 240 participants (123 men; mean age, 70.8 years). These patients became the study’s primary intention-to-treat population.

The study’s primary outcome was the mean change in score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12), which was evaluated at 3-month intervals.

Secondary clinical outcomes were assessed at 6-month intervals. These included the mean change in scores for the Alzheimer Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment and the Clinical Dementia Rating Scale Sum of Boxes.

Safety and adherence were also assessed during each study visit. Physical and neurologic examinations were performed at baseline and at months 6, 12, and 18.

Of the primary intention-to-treat population of 240 patients, 121 were randomly assigned to receive intranasal insulin. The remaining 119 received placebo and served as controls. The two groups were demographically comparable.

Better cognitive performance

A total of 215 participants completed the blinded phase; 198 participants completed the open-label extension. Discontinuation rates were comparable in both arms. The researchers found no differences between groups with respect to mean change in ADAS-cog-12 score from baseline to month 12 (0.0258 points; 95% confidence interval, –1.771 to 1.822 points; P = .98). The two groups also proved comparable in terms of performance on all other cognitive tests.

The open-label portion yielded similar results. Participants originally assigned to the insulin arm and their counterparts in the placebo arm did not differ with respect to mean score change on the ADAS-cog-12 test (or any other outcome) at either month 15 or 18.

Cerebrospinal fluid insulin levels were unchanged between groups, as were blood glucose and hemoglobin A1c values. Indeed, levels of A-beta42, A-beta40, total tau protein, and tau p-181 were comparable for the patients who received intranasal insulin and those who received placebo.

The most common adverse events were infections, injuries, respiratory disorders, and nervous system disorders, though these did not differ between groups. In addition, there were no differences between groups with respect to severity of adverse events; most were rated as mild.

In contrast with the intention-to-treat population, the study’s secondary analysis – using data from the original administration device – yielded markedly different results. In the blinded phase, patients who received insulin had better ADAS-cog-12 performance at 12 months (−2.81 points; 95% CI, −6.09 to 0.45 points; P = .09) and nominally significant effects at 6 months (−3.78 points; 95% CI, −6.79 to −0.78 points; P = .01).

Device type critical

These effects persisted in the open-label analyses. Patients who received intranasal insulin had superior ADAS-cog-12 scores at month 15 (−5.70 points; 95% CI, −9.62 to −1.79 points; P = .004) and month 18 (−5.78 points; 95% CI, −10.55 to −1.01 points; P = .02), compared with their counterparts who received insulin via the second device. This part of the study also showed that, although individual biomarkers did not differ significantly between the two arms, the ratios of A-beta42 to A-beta40 (P = .01) and A-beta42 to total tau (P = .03) increased with use of the first device. The number, type, and severity of adverse events were comparable between the insulin and placebo groups in this arm of the study.

The mixed results revealed by the trial demonstrate that the device used for intranasal insulin administration is paramount in determining the therapy’s potential efficacy. “Our take-home message is that the device is a very important factor for these studies and that one needs to validate their ability to effectively deliver insulin to the CNS,” said Dr. Craft.

“We were quite confident that the first device was able to do that. On the other hand, the second device has never been tested in that way, and we still don’t know whether or not that device was able to successfully deliver insulin,” she said.

The investigators recognize the need for more research in the field. Such studies, Dr. Craft noted, will utilize administration devices that have been previously verified to have the ability to deliver insulin to the central nervous system. “We’re currently testing several devices,” she noted. “We’re using a protocol where we administer insulin with the devices and then conduct a lumbar puncture about 30 minutes later to verify that it is actually raising insulin levels in the cerebrospinal fluid.”

Not a failure

Commenting on the findings, Samuel E. Gandy, MD, PhD, who was not involved in the study, said the research illustrates the challenge when a new therapy, a new delivery device, and a cohort of cognitively impaired patients collide. “The result is not quite a slam dunk but is also by no means a failure,” commented Dr. Gandy, Mount Sinai Chair in Alzheimer’s Research at Mount Sinai Medical Center, New York.

“One looks forward to future iterations of the Craft et al. approach, wherein the trialists tweak the ligand and/or the delivery schedule and/or the device and/or the disease and/or the disease stage,” Dr. Gandy added. “Another ligand, VGF, also holds promise for intranasal delivery, based on work from Steve Salton, Michelle Ehrlich, and Eric Schadt, all from Mount Sinai. Perhaps the nose knows!”

For Dr. Craft, the potential upside of intranasal insulin for these patients is significant and warrants further investigation. “I understand why people who are not familiar with prior research in this area might be skeptical of our enthusiasm, given the results in the intention-to-treat population,” she said. “But those of us who have been working along with this for a while now, we feel like we’ve got to do the next study. But we need to have a device that we know works,” Dr. Craft added.

“If this is real, then there may be a very large clinical benefit in symptomatic patients, and there’s nothing so far that has really improved symptomatic disease.”

The study was supported by the National Institute on Aging. Eli Lilly provided diluent placebo for the blinded phase and insulin for the open-label phase of the clinical trial at no cost. Dr. Craft received grants from the National Institute on Aging and nonfinancial support from Eli Lilly during the conduct of the study and personal fees from T3D Therapeutics and vTv Therapeutics outside the submitted work.

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

A new multicenter trial has yielded conflicting results regarding intranasal insulin’s ability to deliver cognitive and functional benefit for patients with mild cognitive impairment (MCI) and Alzheimer’s disease. The randomized trial of nearly 300 patients showed that, although one insulin administration device produced marked benefit in terms of change in mean score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12) over 12 months, reliability was inconsistent. A second device, used on the majority of patients in the study’s intention-to-treat population, showed no difference in these measures between patients who did and those who did not receive intranasal insulin.

“The primary analysis of the study showed no benefit of intranasal insulin on any measures of cognition or cerebrospinal fluid Alzheimer’s disease biomarkers when using the new device,” said principal investigator Suzanne Craft, PhD.

“But when we looked at our planned secondary analysis with the original device – which has been successful in previous studies – we saw quite a different picture,” added Dr. Craft, director of the Alzheimer’s Disease Research Center at Wake Forest University, Winston-Salem, N.C.

“We found a pronounced benefit with that device, such that after 18 months of administration, participants who had been receiving insulin from the beginning of the study had a large and clinically significant advantage in the primary outcome measure.”

Dr. Craft described the findings as complex. “The primary results were negative,” she added. “But the secondary results replicated those of several earlier studies when we used the same device that was used in those.”

The study was published online June 22 in JAMA Neurology.

Important for brain function

Insulin has been shown to play several important roles in brain function. The hormone is associated with a variety of cognitive functions, including memory. Through its association with vasoreactivity, lipid metabolism, and inflammation, insulin also plays an important role in vascular function.

“In the normal brain in healthy individuals, insulin is very important for synaptic function and viability. Insulin also promotes dendritic growth and facilitates synaptic health. Through this role, it plays an important part in memory,” said Dr. Craft. Given these connections, it is not surprising that reduced insulin levels or activity in brain and cerebrospinal fluid have been documented in some, but not all, studies of Alzheimer’s disease. Markers of insulin resistance also have been detected in both neuronally derived exosomes and brain tissue from adults with Alzheimer’s disease.

In light of the several important roles that insulin plays in the brain – coupled with the evidence connecting dysregulation of brain insulin and AD pathology – restoring brain insulin function may offer therapeutic benefit for adults suffering either Alzheimer’s disease or MCI. “There are a number of ways to do this,” said Dr. Craft. “But one of the approaches that we’ve focused on is providing insulin directly to the brain through intranasal administration. “By doing this, you circumvent potential issues if you administered insulin systemically.”

Previous research has shown that through this mode of administration, insulin can bypass the blood-brain barrier and reach the brain through olfactory and trigeminal perivascular channels, with little effect on peripheral insulin or blood glucose levels.

As previously reported, an earlier pilot study, also conducted by Dr. Craft and her team, showed that 4 months of daily intranasal administration of 20 IU or 40 IU of insulin preserved cognitive performance in individuals with Alzheimer’s disease or MCI.

Deeper dive

In the current investigation, the researchers wanted to broaden these findings in a larger, longer, randomized double-blinded clinical trial. The investigators assessed the efficacy of intranasal insulin on cognition, function, and biomarkers of Alzheimer’s disease, as well as the safety and feasibility of the delivery method. The multicenter trial was conducted from 2014 to 2018 and included 27 sites.

Study participants were between the ages of 55 and 85 years and had been diagnosed with amnestic MCI or Alzheimer’s disease on the basis of National Institute on Aging–Alzheimer Association criteria, a score of 20 or higher on the Mini–Mental State Examination, a clinical dementia rating of 0.5 or 1.0, or a delayed logical memory score within a specified range.

In total, 289 participants were randomly assigned to receive 40 IU of insulin or placebo for 12 months, followed by a 6-month open-label extension phase. The first 49 participants (32 men; mean age, 71.9 years) underwent insulin administration with the same device the investigators used in previous trials.

Of these, 45 completed the blinded phase, and 42 completed the open-label extension. When this device, which uses an electronic nebulizer-like delivery system, proved unreliable, the researchers switched to a second device, which uses a liquid hydrofluoroalkane propellant to deliver a metered dose of insulin through a nose tip without electronic assistance. Device 2 was used for the remaining 240 participants (123 men; mean age, 70.8 years). These patients became the study’s primary intention-to-treat population.

The study’s primary outcome was the mean change in score on the Alzheimer Disease Assessment Scale–Cognitive Subscale 12 (ADAS-cog-12), which was evaluated at 3-month intervals.

Secondary clinical outcomes were assessed at 6-month intervals. These included the mean change in scores for the Alzheimer Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment and the Clinical Dementia Rating Scale Sum of Boxes.

Safety and adherence were also assessed during each study visit. Physical and neurologic examinations were performed at baseline and at months 6, 12, and 18.

Of the primary intention-to-treat population of 240 patients, 121 were randomly assigned to receive intranasal insulin. The remaining 119 received placebo and served as controls. The two groups were demographically comparable.

Better cognitive performance

A total of 215 participants completed the blinded phase; 198 participants completed the open-label extension. Discontinuation rates were comparable in both arms. The researchers found no differences between groups with respect to mean change in ADAS-cog-12 score from baseline to month 12 (0.0258 points; 95% confidence interval, –1.771 to 1.822 points; P = .98). The two groups also proved comparable in terms of performance on all other cognitive tests.

The open-label portion yielded similar results. Participants originally assigned to the insulin arm and their counterparts in the placebo arm did not differ with respect to mean score change on the ADAS-cog-12 test (or any other outcome) at either month 15 or 18.

Cerebrospinal fluid insulin levels were unchanged between groups, as were blood glucose and hemoglobin A1c values. Indeed, levels of A-beta42, A-beta40, total tau protein, and tau p-181 were comparable for the patients who received intranasal insulin and those who received placebo.

The most common adverse events were infections, injuries, respiratory disorders, and nervous system disorders, though these did not differ between groups. In addition, there were no differences between groups with respect to severity of adverse events; most were rated as mild.

In contrast with the intention-to-treat population, the study’s secondary analysis – using data from the original administration device – yielded markedly different results. In the blinded phase, patients who received insulin had better ADAS-cog-12 performance at 12 months (−2.81 points; 95% CI, −6.09 to 0.45 points; P = .09) and nominally significant effects at 6 months (−3.78 points; 95% CI, −6.79 to −0.78 points; P = .01).

Device type critical

These effects persisted in the open-label analyses. Patients who received intranasal insulin had superior ADAS-cog-12 scores at month 15 (−5.70 points; 95% CI, −9.62 to −1.79 points; P = .004) and month 18 (−5.78 points; 95% CI, −10.55 to −1.01 points; P = .02), compared with their counterparts who received insulin via the second device. This part of the study also showed that, although individual biomarkers did not differ significantly between the two arms, the ratios of A-beta42 to A-beta40 (P = .01) and A-beta42 to total tau (P = .03) increased with use of the first device. The number, type, and severity of adverse events were comparable between the insulin and placebo groups in this arm of the study.

The mixed results revealed by the trial demonstrate that the device used for intranasal insulin administration is paramount in determining the therapy’s potential efficacy. “Our take-home message is that the device is a very important factor for these studies and that one needs to validate their ability to effectively deliver insulin to the CNS,” said Dr. Craft.

“We were quite confident that the first device was able to do that. On the other hand, the second device has never been tested in that way, and we still don’t know whether or not that device was able to successfully deliver insulin,” she said.

The investigators recognize the need for more research in the field. Such studies, Dr. Craft noted, will utilize administration devices that have been previously verified to have the ability to deliver insulin to the central nervous system. “We’re currently testing several devices,” she noted. “We’re using a protocol where we administer insulin with the devices and then conduct a lumbar puncture about 30 minutes later to verify that it is actually raising insulin levels in the cerebrospinal fluid.”

Not a failure

Commenting on the findings, Samuel E. Gandy, MD, PhD, who was not involved in the study, said the research illustrates the challenge when a new therapy, a new delivery device, and a cohort of cognitively impaired patients collide. “The result is not quite a slam dunk but is also by no means a failure,” commented Dr. Gandy, Mount Sinai Chair in Alzheimer’s Research at Mount Sinai Medical Center, New York.

“One looks forward to future iterations of the Craft et al. approach, wherein the trialists tweak the ligand and/or the delivery schedule and/or the device and/or the disease and/or the disease stage,” Dr. Gandy added. “Another ligand, VGF, also holds promise for intranasal delivery, based on work from Steve Salton, Michelle Ehrlich, and Eric Schadt, all from Mount Sinai. Perhaps the nose knows!”

For Dr. Craft, the potential upside of intranasal insulin for these patients is significant and warrants further investigation. “I understand why people who are not familiar with prior research in this area might be skeptical of our enthusiasm, given the results in the intention-to-treat population,” she said. “But those of us who have been working along with this for a while now, we feel like we’ve got to do the next study. But we need to have a device that we know works,” Dr. Craft added.

“If this is real, then there may be a very large clinical benefit in symptomatic patients, and there’s nothing so far that has really improved symptomatic disease.”

The study was supported by the National Institute on Aging. Eli Lilly provided diluent placebo for the blinded phase and insulin for the open-label phase of the clinical trial at no cost. Dr. Craft received grants from the National Institute on Aging and nonfinancial support from Eli Lilly during the conduct of the study and personal fees from T3D Therapeutics and vTv Therapeutics outside the submitted work.

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

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

Primary extramammary Paget disease (EMPD) is an adnexal carcinoma of the apocrine gland ducts that presents as an erythematous patch on cutaneous sites rich with apocrine glands.¹ Primary EMPD can be in situ or invasive with the potential to become metastatic.² Treatment of primary EMPD is challenging due to the difficulty of achieving clear surgical margins, as the tumor has microscopic spread throughout the epidermis in a skipping fashion.³ Mohs micrographic surgery is the treatment of choice; however, there is a clinical need to identify additional treatment modalities, especially for patients with unresectable, invasive, or metastatic primary EMPD,⁴ which partly is due to lack of data to understand the pathogenesis of primary EMPD. Recently, there have been studies investigating the genetic characteristics of EMPD tumors. The interaction between the programmed cell death receptor 1 (PD-1) and its ligand (PD-L1) is one of the pathways recently studied and has been reported to be a potential target in EMPD.^5-7 Programmed cell death receptor 1 signaling constitutes an immune checkpoint pathway that regulates the activation of tumor-specific T cells.⁸ In several malignancies, cancer cells express PD-L1 on their surface to activate PD-1 signaling in T cells as a mechanism to dampen the tumor-specific immune response and evade antitumor immunity.⁹ Thus, blocking PD-1 signaling widely is used to activate tumor-specific T cells and decrease tumor burden.¹⁰ Given the advances of immunotherapy in many neoplasms and the paucity of effective agents to treat EMPD, this article serves to shed light on recent data studying PD-1 signaling in EMPD and highlights the potential clinical use of immunotherapy for EMPD.

EMPD and Its Subtypes

Extramammary Paget disease is a rare adenocarcinoma typically affecting older patients (age >60 years) in cutaneous sites with abundant apocrine glands such as the genital and perianal skin.³ Extramammary Paget disease presents as an erythematous patch and frequently is treated initially as a skin dermatosis, resulting in a delay in diagnosis. Histologically, EMPD is characterized by the presence of single cells or a nest of cells having abundant pale cytoplasm and large vesicular nuclei distributed in the epidermis in a pagetoid fashion.¹¹

Extramammary Paget disease can be primary or secondary; the 2 subtypes behave differently both clinically and prognostically. Although primary EMPD is considered to be an adnexal carcinoma of the apocrine gland ducts, secondary EMPD is considered to be an intraepithelial extension of malignant cells from an underlying internal neoplasm.¹² The underlying malignancies usually are located within dermal adnexal glands or organs in the vicinity of the cutaneous lesion, such as the colon in the case of perianal EMPD. Histologically, primary and secondary EMPD can be differentiated based on their immunophenotypic staining profiles. Although all cases of EMPD show positive immunohistochemistry staining for cytokeratin 7, carcinoembryonic antigen, and epithelial membrane antigen, only primary EMPD will additionally stain for GCDFP-15 (gross cystic disease fluid protein 15) and GATA.¹¹ Regardless of the immunohistochemistry stains, every patient newly diagnosed with EMPD deserves a full workup for malignancy screening, including a colonoscopy, cystoscopy, mammography and Papanicolaou test in women, pelvic ultrasound, and computed tomography of the abdomen and pelvis.¹³

The first-line treatment of EMPD is surgery; however, obtaining clear surgical margins can be a challenge, with high recurrence rates due to the microscopic spread of the disease throughout the epidermis.⁴ In addition, anatomic location affects the surgical approach and patient survival. Recent studies on EMPD mortality outcomes in women show that mortality is higher in patients with vaginal EMPD than in those with vulvar/labial EMPD, partly due to the sensitive location that makes it difficult to perform wide local excisions.^13,14 Assessing the entire margins with tissue preservation using Mohs micrographic surgery has been shown to be successful in decreasing the recurrence rate, especially when coupled with the use of cytokeratin 7 immunohistochemistry.⁴ Other treatment modalities include radiation, topical imiquimod, and photodynamic therapy.^15,16 Regardless of treatment modality, EMPD requires long‐term follow-up to monitor for disease recurrence, regional lymphadenopathy, distant metastasis, or development of an internal malignancy.

The pathogenesis of primary EMPD remains unclear. The tumor is thought to be derived from Toker cells, which are pluripotent adnexal stem cells located in the epidermis that normally give rise to apocrine glands.¹⁷ There have been few studies investigating the genetic characteristics of EMPD lesions in an attempt to understand pathogenesis as well as to find druggable targets. Current data for targeted therapy have focused on HER2 (human epidermal growth factor receptor 2) hormone receptor expression,¹⁸ ERBB (erythroblastic oncogene B) amplification,¹⁹ CDK4 (cyclin-dependent kinase 4)–cyclin D1 signaling,²⁰ and most recently PD-1/PD-L1 pathway.^5-7

PD-1 Expression in EMPD: Implication for Immunotherapy

Most tumors display novel antigens that are recognized by the host immune system and thus stimulate cell-mediated and humoral pathways. The immune system naturally provides regulatory immune checkpoints to T cell–mediated immune responses. One of these checkpoints involves the interaction between PD-1 on T cells and its ligand PD-L1 on tumor cells.²¹ When PD-1 binds to PD-L1 on tumor cells, there is inhibition of T-cell proliferation, a decrease in cytokine production, and induction of T-cell cytolysis.²² The Figure summarizes the dynamics for T-cell regulation.

Naturally, tumor-infiltrating T cells trigger their own inhibition by binding to PD-L1. However, certain tumor cells constitutively upregulate the expression of PD-L1. With that, the tumor cells gain the ability to suppress T cells and avoid T cell–mediated cytotoxicity,²³ which is known as the adoptive immune resistance mechanism. There have been several studies in the literature investigating the PD-1 signaling pathway in EMPD as a way to determine if EMPD would be susceptible to immune checkpoint blockade. The success of checkpoint inhibitor immunotherapy generally correlates with increased PD-L1 expression by tumor cells.

One study evaluated the expression of PD-L1 in tumor cells and tumor-infiltrating T cells in 18 cases of EMPD.⁶ The authors identified that even though tumor cell PD-L1 expression was detected in only 3 (17%) cases, tumor-infiltrating lymphocytes expressed PD-L1 in the majority of the cases analyzed and in all of the cases positive for tumor cell PD-L1.⁶

Another study evaluated PD-1 and PD-L1 expression in EMPD tumor cells and tumor-associated immune infiltrate.⁵ They found that PD-1 was expressed heavily by the tumor-associated immune infiltrate in all EMPD cases analyzed. Similar to the previously mentioned study,⁶ PD-L1 was expressed by tumor cells in a few cases only. Interestingly, they found that the density of CD3 in the tumor-associated immune infiltrate was significantly (P=.049) higher in patients who were alive than in those who died, suggesting the importance of an exuberant T-cell response for survival in EMPD.⁵

A third study investigated protein expression of the B7 family members as well as PD-1 and PD-L1/2 in 55 EMPD samples. In this study the authors also found that tumor cell PD-L1 was minimal. Interestingly, they also found that tumor cells expressed B7 proteins in the majority of the cases.⁷

Finally, another study examined activity levels of T cells in EMPD by measuring the number and expression levels of cytotoxic T-cell cytokines.²⁴ The authors first found that EMPD tumors had a significantly higher number of CD8⁺ tumor-infiltrating lymphocytes compared to peripheral blood (P<.01). These CD8⁺ tumor-infiltrating lymphocytes also had a significantly higher expression of PD-1 (P<.01). They also found that tumor cells produced an immunosuppressive molecule called indoleamine 2,3-dyoxygenae that functions by suppressing T-cell activity levels. They concluded that in EMPD, tumor-specific T lymphocytes have an exhausted phenotype due to PD-1 activation as well as indoleamine 2,3-dyoxygenase release to the tumor microenvironment.²⁴

These studies highlight that restoring the effector functions of tumor-specific T lymphocytes could be an effective treatment strategy for EMPD. In fact, immunotherapy has been used with success for EMPD in the form of topical immunomodulators such as imiquimod.^16,25 More than 40 cases of EMPD treated with imiquimod 5% have been published; of these, only 6 were considered nonresponders,⁵ which suggests that EMPD may respond to other immunotherapies such as checkpoint inhibitors. It is an exciting time for immunotherapy as more checkpoint inhibitors are being developed. Among the newer agents is cemiplimab, which is a PD-1 inhibitor now US Food and Drug Administration approved for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation.²⁶ Programmed cell death receptor 1 signaling can serve as a potential target in EMPD, and further studies need to be performed to test the clinical efficacy, especially in unresectable or invasive/metastatic EMPD. As the PD-1 pathway is more studied in EMPD, and as more PD-1 inhibitors get developed, it would be a clinical need to establish clinical studies for PD-1 inhibitors in EMPD.

Primary extramammary Paget disease (EMPD) is an adnexal carcinoma of the apocrine gland ducts that presents as an erythematous patch on cutaneous sites rich with apocrine glands.¹ Primary EMPD can be in situ or invasive with the potential to become metastatic.² Treatment of primary EMPD is challenging due to the difficulty of achieving clear surgical margins, as the tumor has microscopic spread throughout the epidermis in a skipping fashion.³ Mohs micrographic surgery is the treatment of choice; however, there is a clinical need to identify additional treatment modalities, especially for patients with unresectable, invasive, or metastatic primary EMPD,⁴ which partly is due to lack of data to understand the pathogenesis of primary EMPD. Recently, there have been studies investigating the genetic characteristics of EMPD tumors. The interaction between the programmed cell death receptor 1 (PD-1) and its ligand (PD-L1) is one of the pathways recently studied and has been reported to be a potential target in EMPD.^5-7 Programmed cell death receptor 1 signaling constitutes an immune checkpoint pathway that regulates the activation of tumor-specific T cells.⁸ In several malignancies, cancer cells express PD-L1 on their surface to activate PD-1 signaling in T cells as a mechanism to dampen the tumor-specific immune response and evade antitumor immunity.⁹ Thus, blocking PD-1 signaling widely is used to activate tumor-specific T cells and decrease tumor burden.¹⁰ Given the advances of immunotherapy in many neoplasms and the paucity of effective agents to treat EMPD, this article serves to shed light on recent data studying PD-1 signaling in EMPD and highlights the potential clinical use of immunotherapy for EMPD.

EMPD and Its Subtypes

Extramammary Paget disease is a rare adenocarcinoma typically affecting older patients (age >60 years) in cutaneous sites with abundant apocrine glands such as the genital and perianal skin.³ Extramammary Paget disease presents as an erythematous patch and frequently is treated initially as a skin dermatosis, resulting in a delay in diagnosis. Histologically, EMPD is characterized by the presence of single cells or a nest of cells having abundant pale cytoplasm and large vesicular nuclei distributed in the epidermis in a pagetoid fashion.¹¹

Extramammary Paget disease can be primary or secondary; the 2 subtypes behave differently both clinically and prognostically. Although primary EMPD is considered to be an adnexal carcinoma of the apocrine gland ducts, secondary EMPD is considered to be an intraepithelial extension of malignant cells from an underlying internal neoplasm.¹² The underlying malignancies usually are located within dermal adnexal glands or organs in the vicinity of the cutaneous lesion, such as the colon in the case of perianal EMPD. Histologically, primary and secondary EMPD can be differentiated based on their immunophenotypic staining profiles. Although all cases of EMPD show positive immunohistochemistry staining for cytokeratin 7, carcinoembryonic antigen, and epithelial membrane antigen, only primary EMPD will additionally stain for GCDFP-15 (gross cystic disease fluid protein 15) and GATA.¹¹ Regardless of the immunohistochemistry stains, every patient newly diagnosed with EMPD deserves a full workup for malignancy screening, including a colonoscopy, cystoscopy, mammography and Papanicolaou test in women, pelvic ultrasound, and computed tomography of the abdomen and pelvis.¹³

The first-line treatment of EMPD is surgery; however, obtaining clear surgical margins can be a challenge, with high recurrence rates due to the microscopic spread of the disease throughout the epidermis.⁴ In addition, anatomic location affects the surgical approach and patient survival. Recent studies on EMPD mortality outcomes in women show that mortality is higher in patients with vaginal EMPD than in those with vulvar/labial EMPD, partly due to the sensitive location that makes it difficult to perform wide local excisions.^13,14 Assessing the entire margins with tissue preservation using Mohs micrographic surgery has been shown to be successful in decreasing the recurrence rate, especially when coupled with the use of cytokeratin 7 immunohistochemistry.⁴ Other treatment modalities include radiation, topical imiquimod, and photodynamic therapy.^15,16 Regardless of treatment modality, EMPD requires long‐term follow-up to monitor for disease recurrence, regional lymphadenopathy, distant metastasis, or development of an internal malignancy.

The pathogenesis of primary EMPD remains unclear. The tumor is thought to be derived from Toker cells, which are pluripotent adnexal stem cells located in the epidermis that normally give rise to apocrine glands.¹⁷ There have been few studies investigating the genetic characteristics of EMPD lesions in an attempt to understand pathogenesis as well as to find druggable targets. Current data for targeted therapy have focused on HER2 (human epidermal growth factor receptor 2) hormone receptor expression,¹⁸ ERBB (erythroblastic oncogene B) amplification,¹⁹ CDK4 (cyclin-dependent kinase 4)–cyclin D1 signaling,²⁰ and most recently PD-1/PD-L1 pathway.^5-7

PD-1 Expression in EMPD: Implication for Immunotherapy

Most tumors display novel antigens that are recognized by the host immune system and thus stimulate cell-mediated and humoral pathways. The immune system naturally provides regulatory immune checkpoints to T cell–mediated immune responses. One of these checkpoints involves the interaction between PD-1 on T cells and its ligand PD-L1 on tumor cells.²¹ When PD-1 binds to PD-L1 on tumor cells, there is inhibition of T-cell proliferation, a decrease in cytokine production, and induction of T-cell cytolysis.²² The Figure summarizes the dynamics for T-cell regulation.

Naturally, tumor-infiltrating T cells trigger their own inhibition by binding to PD-L1. However, certain tumor cells constitutively upregulate the expression of PD-L1. With that, the tumor cells gain the ability to suppress T cells and avoid T cell–mediated cytotoxicity,²³ which is known as the adoptive immune resistance mechanism. There have been several studies in the literature investigating the PD-1 signaling pathway in EMPD as a way to determine if EMPD would be susceptible to immune checkpoint blockade. The success of checkpoint inhibitor immunotherapy generally correlates with increased PD-L1 expression by tumor cells.

One study evaluated the expression of PD-L1 in tumor cells and tumor-infiltrating T cells in 18 cases of EMPD.⁶ The authors identified that even though tumor cell PD-L1 expression was detected in only 3 (17%) cases, tumor-infiltrating lymphocytes expressed PD-L1 in the majority of the cases analyzed and in all of the cases positive for tumor cell PD-L1.⁶

Another study evaluated PD-1 and PD-L1 expression in EMPD tumor cells and tumor-associated immune infiltrate.⁵ They found that PD-1 was expressed heavily by the tumor-associated immune infiltrate in all EMPD cases analyzed. Similar to the previously mentioned study,⁶ PD-L1 was expressed by tumor cells in a few cases only. Interestingly, they found that the density of CD3 in the tumor-associated immune infiltrate was significantly (P=.049) higher in patients who were alive than in those who died, suggesting the importance of an exuberant T-cell response for survival in EMPD.⁵

A third study investigated protein expression of the B7 family members as well as PD-1 and PD-L1/2 in 55 EMPD samples. In this study the authors also found that tumor cell PD-L1 was minimal. Interestingly, they also found that tumor cells expressed B7 proteins in the majority of the cases.⁷

Finally, another study examined activity levels of T cells in EMPD by measuring the number and expression levels of cytotoxic T-cell cytokines.²⁴ The authors first found that EMPD tumors had a significantly higher number of CD8⁺ tumor-infiltrating lymphocytes compared to peripheral blood (P<.01). These CD8⁺ tumor-infiltrating lymphocytes also had a significantly higher expression of PD-1 (P<.01). They also found that tumor cells produced an immunosuppressive molecule called indoleamine 2,3-dyoxygenae that functions by suppressing T-cell activity levels. They concluded that in EMPD, tumor-specific T lymphocytes have an exhausted phenotype due to PD-1 activation as well as indoleamine 2,3-dyoxygenase release to the tumor microenvironment.²⁴

These studies highlight that restoring the effector functions of tumor-specific T lymphocytes could be an effective treatment strategy for EMPD. In fact, immunotherapy has been used with success for EMPD in the form of topical immunomodulators such as imiquimod.^16,25 More than 40 cases of EMPD treated with imiquimod 5% have been published; of these, only 6 were considered nonresponders,⁵ which suggests that EMPD may respond to other immunotherapies such as checkpoint inhibitors. It is an exciting time for immunotherapy as more checkpoint inhibitors are being developed. Among the newer agents is cemiplimab, which is a PD-1 inhibitor now US Food and Drug Administration approved for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation.²⁶ Programmed cell death receptor 1 signaling can serve as a potential target in EMPD, and further studies need to be performed to test the clinical efficacy, especially in unresectable or invasive/metastatic EMPD. As the PD-1 pathway is more studied in EMPD, and as more PD-1 inhibitors get developed, it would be a clinical need to establish clinical studies for PD-1 inhibitors in EMPD.

Primary extramammary Paget disease (EMPD) is an adnexal carcinoma of the apocrine gland ducts that presents as an erythematous patch on cutaneous sites rich with apocrine glands.¹ Primary EMPD can be in situ or invasive with the potential to become metastatic.² Treatment of primary EMPD is challenging due to the difficulty of achieving clear surgical margins, as the tumor has microscopic spread throughout the epidermis in a skipping fashion.³ Mohs micrographic surgery is the treatment of choice; however, there is a clinical need to identify additional treatment modalities, especially for patients with unresectable, invasive, or metastatic primary EMPD,⁴ which partly is due to lack of data to understand the pathogenesis of primary EMPD. Recently, there have been studies investigating the genetic characteristics of EMPD tumors. The interaction between the programmed cell death receptor 1 (PD-1) and its ligand (PD-L1) is one of the pathways recently studied and has been reported to be a potential target in EMPD.^5-7 Programmed cell death receptor 1 signaling constitutes an immune checkpoint pathway that regulates the activation of tumor-specific T cells.⁸ In several malignancies, cancer cells express PD-L1 on their surface to activate PD-1 signaling in T cells as a mechanism to dampen the tumor-specific immune response and evade antitumor immunity.⁹ Thus, blocking PD-1 signaling widely is used to activate tumor-specific T cells and decrease tumor burden.¹⁰ Given the advances of immunotherapy in many neoplasms and the paucity of effective agents to treat EMPD, this article serves to shed light on recent data studying PD-1 signaling in EMPD and highlights the potential clinical use of immunotherapy for EMPD.

EMPD and Its Subtypes

Extramammary Paget disease is a rare adenocarcinoma typically affecting older patients (age >60 years) in cutaneous sites with abundant apocrine glands such as the genital and perianal skin.³ Extramammary Paget disease presents as an erythematous patch and frequently is treated initially as a skin dermatosis, resulting in a delay in diagnosis. Histologically, EMPD is characterized by the presence of single cells or a nest of cells having abundant pale cytoplasm and large vesicular nuclei distributed in the epidermis in a pagetoid fashion.¹¹

Extramammary Paget disease can be primary or secondary; the 2 subtypes behave differently both clinically and prognostically. Although primary EMPD is considered to be an adnexal carcinoma of the apocrine gland ducts, secondary EMPD is considered to be an intraepithelial extension of malignant cells from an underlying internal neoplasm.¹² The underlying malignancies usually are located within dermal adnexal glands or organs in the vicinity of the cutaneous lesion, such as the colon in the case of perianal EMPD. Histologically, primary and secondary EMPD can be differentiated based on their immunophenotypic staining profiles. Although all cases of EMPD show positive immunohistochemistry staining for cytokeratin 7, carcinoembryonic antigen, and epithelial membrane antigen, only primary EMPD will additionally stain for GCDFP-15 (gross cystic disease fluid protein 15) and GATA.¹¹ Regardless of the immunohistochemistry stains, every patient newly diagnosed with EMPD deserves a full workup for malignancy screening, including a colonoscopy, cystoscopy, mammography and Papanicolaou test in women, pelvic ultrasound, and computed tomography of the abdomen and pelvis.¹³

The first-line treatment of EMPD is surgery; however, obtaining clear surgical margins can be a challenge, with high recurrence rates due to the microscopic spread of the disease throughout the epidermis.⁴ In addition, anatomic location affects the surgical approach and patient survival. Recent studies on EMPD mortality outcomes in women show that mortality is higher in patients with vaginal EMPD than in those with vulvar/labial EMPD, partly due to the sensitive location that makes it difficult to perform wide local excisions.^13,14 Assessing the entire margins with tissue preservation using Mohs micrographic surgery has been shown to be successful in decreasing the recurrence rate, especially when coupled with the use of cytokeratin 7 immunohistochemistry.⁴ Other treatment modalities include radiation, topical imiquimod, and photodynamic therapy.^15,16 Regardless of treatment modality, EMPD requires long‐term follow-up to monitor for disease recurrence, regional lymphadenopathy, distant metastasis, or development of an internal malignancy.

The pathogenesis of primary EMPD remains unclear. The tumor is thought to be derived from Toker cells, which are pluripotent adnexal stem cells located in the epidermis that normally give rise to apocrine glands.¹⁷ There have been few studies investigating the genetic characteristics of EMPD lesions in an attempt to understand pathogenesis as well as to find druggable targets. Current data for targeted therapy have focused on HER2 (human epidermal growth factor receptor 2) hormone receptor expression,¹⁸ ERBB (erythroblastic oncogene B) amplification,¹⁹ CDK4 (cyclin-dependent kinase 4)–cyclin D1 signaling,²⁰ and most recently PD-1/PD-L1 pathway.^5-7

PD-1 Expression in EMPD: Implication for Immunotherapy

Most tumors display novel antigens that are recognized by the host immune system and thus stimulate cell-mediated and humoral pathways. The immune system naturally provides regulatory immune checkpoints to T cell–mediated immune responses. One of these checkpoints involves the interaction between PD-1 on T cells and its ligand PD-L1 on tumor cells.²¹ When PD-1 binds to PD-L1 on tumor cells, there is inhibition of T-cell proliferation, a decrease in cytokine production, and induction of T-cell cytolysis.²² The Figure summarizes the dynamics for T-cell regulation.

Naturally, tumor-infiltrating T cells trigger their own inhibition by binding to PD-L1. However, certain tumor cells constitutively upregulate the expression of PD-L1. With that, the tumor cells gain the ability to suppress T cells and avoid T cell–mediated cytotoxicity,²³ which is known as the adoptive immune resistance mechanism. There have been several studies in the literature investigating the PD-1 signaling pathway in EMPD as a way to determine if EMPD would be susceptible to immune checkpoint blockade. The success of checkpoint inhibitor immunotherapy generally correlates with increased PD-L1 expression by tumor cells.

One study evaluated the expression of PD-L1 in tumor cells and tumor-infiltrating T cells in 18 cases of EMPD.⁶ The authors identified that even though tumor cell PD-L1 expression was detected in only 3 (17%) cases, tumor-infiltrating lymphocytes expressed PD-L1 in the majority of the cases analyzed and in all of the cases positive for tumor cell PD-L1.⁶

Another study evaluated PD-1 and PD-L1 expression in EMPD tumor cells and tumor-associated immune infiltrate.⁵ They found that PD-1 was expressed heavily by the tumor-associated immune infiltrate in all EMPD cases analyzed. Similar to the previously mentioned study,⁶ PD-L1 was expressed by tumor cells in a few cases only. Interestingly, they found that the density of CD3 in the tumor-associated immune infiltrate was significantly (P=.049) higher in patients who were alive than in those who died, suggesting the importance of an exuberant T-cell response for survival in EMPD.⁵

A third study investigated protein expression of the B7 family members as well as PD-1 and PD-L1/2 in 55 EMPD samples. In this study the authors also found that tumor cell PD-L1 was minimal. Interestingly, they also found that tumor cells expressed B7 proteins in the majority of the cases.⁷

Finally, another study examined activity levels of T cells in EMPD by measuring the number and expression levels of cytotoxic T-cell cytokines.²⁴ The authors first found that EMPD tumors had a significantly higher number of CD8⁺ tumor-infiltrating lymphocytes compared to peripheral blood (P<.01). These CD8⁺ tumor-infiltrating lymphocytes also had a significantly higher expression of PD-1 (P<.01). They also found that tumor cells produced an immunosuppressive molecule called indoleamine 2,3-dyoxygenae that functions by suppressing T-cell activity levels. They concluded that in EMPD, tumor-specific T lymphocytes have an exhausted phenotype due to PD-1 activation as well as indoleamine 2,3-dyoxygenase release to the tumor microenvironment.²⁴

These studies highlight that restoring the effector functions of tumor-specific T lymphocytes could be an effective treatment strategy for EMPD. In fact, immunotherapy has been used with success for EMPD in the form of topical immunomodulators such as imiquimod.^16,25 More than 40 cases of EMPD treated with imiquimod 5% have been published; of these, only 6 were considered nonresponders,⁵ which suggests that EMPD may respond to other immunotherapies such as checkpoint inhibitors. It is an exciting time for immunotherapy as more checkpoint inhibitors are being developed. Among the newer agents is cemiplimab, which is a PD-1 inhibitor now US Food and Drug Administration approved for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation.²⁶ Programmed cell death receptor 1 signaling can serve as a potential target in EMPD, and further studies need to be performed to test the clinical efficacy, especially in unresectable or invasive/metastatic EMPD. As the PD-1 pathway is more studied in EMPD, and as more PD-1 inhibitors get developed, it would be a clinical need to establish clinical studies for PD-1 inhibitors in EMPD.

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

The coronavirus pandemic has fundamentally altered American health care. At our academic medical center in Brooklyn, a large safety net institution, clinical year medical students are normally integral members of the team consistent with the model of “value-added medical education.”¹ With the suspension of clinical rotations on March 13, 2020, a key part of the workforce was suddenly withdrawn while demand skyrocketed.

In response, students self-organized into numerous remote support projects, including the project described below.

Under infection control regulations, a “no-visitor” policy was instituted. Concurrently, the dramatic increase in patient volume left clinicians unable to regularly update patients’ families. To address this gap, a family contact line was created.

A dedicated phone number was distributed to key hospital personnel to share with families seeking information. The work flow for returning calls is shown in the figure. After verifying patient information and the caller’s relation, students provide updates based on chart review. Calls are prefaced with the disclaimer that students are not part of the treatment team and can only give information that is accessible via the electronic medical record.

Students created a phone script in conjunction with faculty, as well as a referral system for those seeking specific information from other departments. This script undergoes daily revision after the student huddle to address new issues. Flow of information is bidirectional: students relay patient updates as well as quarantine precautions and obtain past medical history. This proved essential during the surge of patients, unknown to the hospital and frequently altered, arriving by ambulance. Students document these conversations in the EMR, including family concerns and whether immediate provider follow-up is needed.

Two key limitations were quickly addressed: First, patients requiring ICU-level care have fluctuating courses, and an update based solely on chart review is insufficient. In response, students worked with intensivist teams to create a dedicated call line staffed by providers.

Second, conversations regarding goals of care and end of life concerns were beyond students’ scope. Together with palliative care teams, students developed criteria for flagging families for follow-up by a consulting palliative care attending.

Through working the call line, students received a crash course in empathetically communicating over the phone. Particularly during the worst of the surge, families were afraid and often frustrated at the lack of communication up to that point. Navigating these emotions, learning how to update family members while removed from the teams, and educating callers on quarantine precautions and other concerns was a valuable learning experience.

As students, we have been exposed to many of the realities of communicating as a physician. Relaying updates and prognosis to family while also providing emotional support is not something we are taught in medical school, but is something we will be expected to handle our first night on the wards as an intern. This experience has prepared us well for that and has illuminated missing parts of the medical school curriculum we are working on emphasizing moving forward.

Over the first 2 weeks, students put in 848 volunteer-hours, making 1,438 calls which reached 1,114 different families. We hope our experience proves instructive for other academic medical centers facing similar concerns in coming months. This model allows medical students to be directly involved in patient care during this crisis and shifts these time-intensive conversations away from overwhelmed primary medical teams.
 

Reference

1. Gonzalo JD et al. Value-added clinical systems learning roles for 355 medical students that transform education and health: A guide for building partnerships between 356 medical schools and health systems. Acad Med. 2017;92(5):602-7.
 

Ms. Jaiman is an MD candidate at State University of New York, Brooklyn and a PhD candidate at the National Center of Biological Sciences in Bangalore, India. Mr. Hessburg is an MD/PhD candidate at State University of New York, Brooklyn. Dr. Egelko is a recent graduate of State University of New York, Brooklyn.

The coronavirus pandemic has fundamentally altered American health care. At our academic medical center in Brooklyn, a large safety net institution, clinical year medical students are normally integral members of the team consistent with the model of “value-added medical education.”¹ With the suspension of clinical rotations on March 13, 2020, a key part of the workforce was suddenly withdrawn while demand skyrocketed.

In response, students self-organized into numerous remote support projects, including the project described below.

Under infection control regulations, a “no-visitor” policy was instituted. Concurrently, the dramatic increase in patient volume left clinicians unable to regularly update patients’ families. To address this gap, a family contact line was created.

A dedicated phone number was distributed to key hospital personnel to share with families seeking information. The work flow for returning calls is shown in the figure. After verifying patient information and the caller’s relation, students provide updates based on chart review. Calls are prefaced with the disclaimer that students are not part of the treatment team and can only give information that is accessible via the electronic medical record.

Students created a phone script in conjunction with faculty, as well as a referral system for those seeking specific information from other departments. This script undergoes daily revision after the student huddle to address new issues. Flow of information is bidirectional: students relay patient updates as well as quarantine precautions and obtain past medical history. This proved essential during the surge of patients, unknown to the hospital and frequently altered, arriving by ambulance. Students document these conversations in the EMR, including family concerns and whether immediate provider follow-up is needed.

Two key limitations were quickly addressed: First, patients requiring ICU-level care have fluctuating courses, and an update based solely on chart review is insufficient. In response, students worked with intensivist teams to create a dedicated call line staffed by providers.

Second, conversations regarding goals of care and end of life concerns were beyond students’ scope. Together with palliative care teams, students developed criteria for flagging families for follow-up by a consulting palliative care attending.

Through working the call line, students received a crash course in empathetically communicating over the phone. Particularly during the worst of the surge, families were afraid and often frustrated at the lack of communication up to that point. Navigating these emotions, learning how to update family members while removed from the teams, and educating callers on quarantine precautions and other concerns was a valuable learning experience.

As students, we have been exposed to many of the realities of communicating as a physician. Relaying updates and prognosis to family while also providing emotional support is not something we are taught in medical school, but is something we will be expected to handle our first night on the wards as an intern. This experience has prepared us well for that and has illuminated missing parts of the medical school curriculum we are working on emphasizing moving forward.

Over the first 2 weeks, students put in 848 volunteer-hours, making 1,438 calls which reached 1,114 different families. We hope our experience proves instructive for other academic medical centers facing similar concerns in coming months. This model allows medical students to be directly involved in patient care during this crisis and shifts these time-intensive conversations away from overwhelmed primary medical teams.
 

Reference

1. Gonzalo JD et al. Value-added clinical systems learning roles for 355 medical students that transform education and health: A guide for building partnerships between 356 medical schools and health systems. Acad Med. 2017;92(5):602-7.
 

Ms. Jaiman is an MD candidate at State University of New York, Brooklyn and a PhD candidate at the National Center of Biological Sciences in Bangalore, India. Mr. Hessburg is an MD/PhD candidate at State University of New York, Brooklyn. Dr. Egelko is a recent graduate of State University of New York, Brooklyn.

The coronavirus pandemic has fundamentally altered American health care. At our academic medical center in Brooklyn, a large safety net institution, clinical year medical students are normally integral members of the team consistent with the model of “value-added medical education.”¹ With the suspension of clinical rotations on March 13, 2020, a key part of the workforce was suddenly withdrawn while demand skyrocketed.

In response, students self-organized into numerous remote support projects, including the project described below.

Under infection control regulations, a “no-visitor” policy was instituted. Concurrently, the dramatic increase in patient volume left clinicians unable to regularly update patients’ families. To address this gap, a family contact line was created.

A dedicated phone number was distributed to key hospital personnel to share with families seeking information. The work flow for returning calls is shown in the figure. After verifying patient information and the caller’s relation, students provide updates based on chart review. Calls are prefaced with the disclaimer that students are not part of the treatment team and can only give information that is accessible via the electronic medical record.

Students created a phone script in conjunction with faculty, as well as a referral system for those seeking specific information from other departments. This script undergoes daily revision after the student huddle to address new issues. Flow of information is bidirectional: students relay patient updates as well as quarantine precautions and obtain past medical history. This proved essential during the surge of patients, unknown to the hospital and frequently altered, arriving by ambulance. Students document these conversations in the EMR, including family concerns and whether immediate provider follow-up is needed.

Two key limitations were quickly addressed: First, patients requiring ICU-level care have fluctuating courses, and an update based solely on chart review is insufficient. In response, students worked with intensivist teams to create a dedicated call line staffed by providers.

Second, conversations regarding goals of care and end of life concerns were beyond students’ scope. Together with palliative care teams, students developed criteria for flagging families for follow-up by a consulting palliative care attending.

Through working the call line, students received a crash course in empathetically communicating over the phone. Particularly during the worst of the surge, families were afraid and often frustrated at the lack of communication up to that point. Navigating these emotions, learning how to update family members while removed from the teams, and educating callers on quarantine precautions and other concerns was a valuable learning experience.

As students, we have been exposed to many of the realities of communicating as a physician. Relaying updates and prognosis to family while also providing emotional support is not something we are taught in medical school, but is something we will be expected to handle our first night on the wards as an intern. This experience has prepared us well for that and has illuminated missing parts of the medical school curriculum we are working on emphasizing moving forward.

Over the first 2 weeks, students put in 848 volunteer-hours, making 1,438 calls which reached 1,114 different families. We hope our experience proves instructive for other academic medical centers facing similar concerns in coming months. This model allows medical students to be directly involved in patient care during this crisis and shifts these time-intensive conversations away from overwhelmed primary medical teams.
 

Reference

1. Gonzalo JD et al. Value-added clinical systems learning roles for 355 medical students that transform education and health: A guide for building partnerships between 356 medical schools and health systems. Acad Med. 2017;92(5):602-7.
 

Ms. Jaiman is an MD candidate at State University of New York, Brooklyn and a PhD candidate at the National Center of Biological Sciences in Bangalore, India. Mr. Hessburg is an MD/PhD candidate at State University of New York, Brooklyn. Dr. Egelko is a recent graduate of State University of New York, Brooklyn.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at [email protected].
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at [email protected].
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at [email protected].
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The term “academic hospitalist” has come to mean more than a mere affiliation to an academic medical center (AMC). Academic hospitalists perform various clinical roles like staffing house staff teams, covering nonteaching services, critical care services, procedure teams, night services, medical consultation, and comanagement services.

Over the last decade, academic hospitalists have successfully managed many nonclinical roles in areas like research, medical unit leadership, faculty development, faculty affairs, quality, safety, informatics, utilization review, clinical documentation, throughput, group management, hospital administration, and educational leadership. The role of an academic hospital is as clear as a chocolate martini these days. Here we present some recent trends in academic hospital medicine.

Compensation

SHM State of Hospital Medicine 2018 Report

From SHM’s State of Hospital Medicine report (SoHM)2014 to 2018 data, the median compensation for U.S. academic hospitalists has risen by an average of 5.15% every year, although increases vary by rank.¹ From 2016 to 2018, clinical instructors saw the most significant growth, 11.23% per year, suggesting a need to remain competitive for junior hospitalists. Compensation also varies by geographic area, with the Southern region reporting the highest compensation. Over the last decade, academic hospitalists received, on average, a 28%-35% lower salary, compared with community hospitalists.

Patient population and census

Lower patient encounters and compensation of the academic hospitalists poses the chicken or the egg dilemma. In the 2018 SoHM report, academic hospitalists had an average of 17% fewer encounters. Of note, AMC patients tend to have higher complexity, as measured by the Case Mix Index (CMI – the average diagnosis-related group weight of a hospital).² A higher CMI is a surrogate marker for the diagnostic diversity, clinical complexity, and resource needs of the patient population in the hospital.
 

Productivity and financial metrics

The financial bottom line is a critical aspect, and as a report in the Journal of Hospital Medicine described, all health care executives look at business metrics while making decisions.³ Below are some significant academic and community comparisons from SoHM 2018.

• Collections, encounters, and wRVUs (work relative value units) were highly correlated. All of them were lower for academic hospitalists, corroborating the fact that they see a smaller number of patients. Clinical full-time equivalents (cFTE) is a vernacular of how much of the faculty time is devoted to clinical activities. The academic data from SoHM achieves the same target, as it is standardized to 100% billable clinical activity, so the fact that many academic hospitalists do not work a full-time clinical schedule is not a factor in their lower production.
• Charges had a smaller gap likely because of sicker patients in AMCs. The higher acuity difference can also explain 12% higher wRVU/encounter for academic hospitalists.
• The wRVU/encounter ratio can indicate a few patterns: high acuity of patients in AMCs, higher levels of evaluation and management documentation, or both. As the encounters and charges have the same percentage differences, we would place our bets on the former.
• Compensation per encounter and compensation per wRVU showed that academic hospitalists do get a slight advantage.

CMI and wRVUs

Although the SoHM does not capture information on patient acuity or CMI, we speculate that the relationship between CMI and wRVUs may be more or less linear at lower levels of acuity. However, once level III E/M billing is achieved (assuming there is no critical care provided), wRVUs/encounter plateau, even as acuity continues to increase. This plateau effect may be seen more often in high-acuity AMC settings than in community hospitals.

SHM State of Hospital Medicine 2018 Report

So, in our opinion, compensation models based solely on wRVU production would not do justice for hospitalists in AMC settings since these models would fail to capture the extra work involved with very-high-acuity patients. SoHM 2018 shows the financial support per wRVU for AMC is $45.81, and for the community is $41.28, an 11% difference. We think the higher financial support per wRVU for academic practices may be related to the lost wRVU potential of caring for very-high-acuity patients.

Conclusion

In an academic setting, hospitalists are reforming the field of hospital medicine and defining the ways we could deliver care. They are the pillars of collaboration, education, research, innovation, quality, and safety. It would be increasingly crucial for academic hospitalist leaders to use comparative metrics from SoHM to advocate for their group. The bottom line can be explained by the title of the qualitative study in JHM referenced above: “Collaboration, not calculation.”³

Dr. Chadha is division chief for the division of hospital medicine at the University of Kentucky Healthcare, Lexington. He actively leads efforts of recruiting, scheduling, practice analysis, and operation of the group. He is a first-time member of the practice analysis committee. Ms. Dede is division administrator for the division of hospital medicine at the University of Kentucky Healthcare. She prepares and manages budgets, liaisons with the downstream revenue teams, and contributes to the building of academic compensation models. She is serving in the practice administrators committee for the second year and is currently vice chair of the Executive Council for the Practice Administrators special interest group.

References

1. State of Hospital Medicine Report. https://www.hospitalmedicine.org/practice-management/shms-state-of-hospital-medicine/

2. Deloitte Center for Health Solutions. Academic Medical Centers: Joining forces with community providers for broad benefits and positive outcomes. 2015. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/academic-medical-centers-consolidation.html

3. White AA et al. Collaboration, not calculation: A qualitative study of how hospital executives value hospital medicine groups. J Hosp Med. 2019;14(10):662‐7.

The term “academic hospitalist” has come to mean more than a mere affiliation to an academic medical center (AMC). Academic hospitalists perform various clinical roles like staffing house staff teams, covering nonteaching services, critical care services, procedure teams, night services, medical consultation, and comanagement services.

Over the last decade, academic hospitalists have successfully managed many nonclinical roles in areas like research, medical unit leadership, faculty development, faculty affairs, quality, safety, informatics, utilization review, clinical documentation, throughput, group management, hospital administration, and educational leadership. The role of an academic hospital is as clear as a chocolate martini these days. Here we present some recent trends in academic hospital medicine.

Compensation

SHM State of Hospital Medicine 2018 Report

From SHM’s State of Hospital Medicine report (SoHM)2014 to 2018 data, the median compensation for U.S. academic hospitalists has risen by an average of 5.15% every year, although increases vary by rank.¹ From 2016 to 2018, clinical instructors saw the most significant growth, 11.23% per year, suggesting a need to remain competitive for junior hospitalists. Compensation also varies by geographic area, with the Southern region reporting the highest compensation. Over the last decade, academic hospitalists received, on average, a 28%-35% lower salary, compared with community hospitalists.

Patient population and census

Lower patient encounters and compensation of the academic hospitalists poses the chicken or the egg dilemma. In the 2018 SoHM report, academic hospitalists had an average of 17% fewer encounters. Of note, AMC patients tend to have higher complexity, as measured by the Case Mix Index (CMI – the average diagnosis-related group weight of a hospital).² A higher CMI is a surrogate marker for the diagnostic diversity, clinical complexity, and resource needs of the patient population in the hospital.
 

Productivity and financial metrics

The financial bottom line is a critical aspect, and as a report in the Journal of Hospital Medicine described, all health care executives look at business metrics while making decisions.³ Below are some significant academic and community comparisons from SoHM 2018.

• Collections, encounters, and wRVUs (work relative value units) were highly correlated. All of them were lower for academic hospitalists, corroborating the fact that they see a smaller number of patients. Clinical full-time equivalents (cFTE) is a vernacular of how much of the faculty time is devoted to clinical activities. The academic data from SoHM achieves the same target, as it is standardized to 100% billable clinical activity, so the fact that many academic hospitalists do not work a full-time clinical schedule is not a factor in their lower production.
• Charges had a smaller gap likely because of sicker patients in AMCs. The higher acuity difference can also explain 12% higher wRVU/encounter for academic hospitalists.
• The wRVU/encounter ratio can indicate a few patterns: high acuity of patients in AMCs, higher levels of evaluation and management documentation, or both. As the encounters and charges have the same percentage differences, we would place our bets on the former.
• Compensation per encounter and compensation per wRVU showed that academic hospitalists do get a slight advantage.

CMI and wRVUs

Although the SoHM does not capture information on patient acuity or CMI, we speculate that the relationship between CMI and wRVUs may be more or less linear at lower levels of acuity. However, once level III E/M billing is achieved (assuming there is no critical care provided), wRVUs/encounter plateau, even as acuity continues to increase. This plateau effect may be seen more often in high-acuity AMC settings than in community hospitals.

SHM State of Hospital Medicine 2018 Report

So, in our opinion, compensation models based solely on wRVU production would not do justice for hospitalists in AMC settings since these models would fail to capture the extra work involved with very-high-acuity patients. SoHM 2018 shows the financial support per wRVU for AMC is $45.81, and for the community is $41.28, an 11% difference. We think the higher financial support per wRVU for academic practices may be related to the lost wRVU potential of caring for very-high-acuity patients.

Conclusion

In an academic setting, hospitalists are reforming the field of hospital medicine and defining the ways we could deliver care. They are the pillars of collaboration, education, research, innovation, quality, and safety. It would be increasingly crucial for academic hospitalist leaders to use comparative metrics from SoHM to advocate for their group. The bottom line can be explained by the title of the qualitative study in JHM referenced above: “Collaboration, not calculation.”³

Dr. Chadha is division chief for the division of hospital medicine at the University of Kentucky Healthcare, Lexington. He actively leads efforts of recruiting, scheduling, practice analysis, and operation of the group. He is a first-time member of the practice analysis committee. Ms. Dede is division administrator for the division of hospital medicine at the University of Kentucky Healthcare. She prepares and manages budgets, liaisons with the downstream revenue teams, and contributes to the building of academic compensation models. She is serving in the practice administrators committee for the second year and is currently vice chair of the Executive Council for the Practice Administrators special interest group.

References

1. State of Hospital Medicine Report. https://www.hospitalmedicine.org/practice-management/shms-state-of-hospital-medicine/

2. Deloitte Center for Health Solutions. Academic Medical Centers: Joining forces with community providers for broad benefits and positive outcomes. 2015. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/academic-medical-centers-consolidation.html

3. White AA et al. Collaboration, not calculation: A qualitative study of how hospital executives value hospital medicine groups. J Hosp Med. 2019;14(10):662‐7.

The term “academic hospitalist” has come to mean more than a mere affiliation to an academic medical center (AMC). Academic hospitalists perform various clinical roles like staffing house staff teams, covering nonteaching services, critical care services, procedure teams, night services, medical consultation, and comanagement services.

Over the last decade, academic hospitalists have successfully managed many nonclinical roles in areas like research, medical unit leadership, faculty development, faculty affairs, quality, safety, informatics, utilization review, clinical documentation, throughput, group management, hospital administration, and educational leadership. The role of an academic hospital is as clear as a chocolate martini these days. Here we present some recent trends in academic hospital medicine.

Compensation

SHM State of Hospital Medicine 2018 Report

From SHM’s State of Hospital Medicine report (SoHM)2014 to 2018 data, the median compensation for U.S. academic hospitalists has risen by an average of 5.15% every year, although increases vary by rank.¹ From 2016 to 2018, clinical instructors saw the most significant growth, 11.23% per year, suggesting a need to remain competitive for junior hospitalists. Compensation also varies by geographic area, with the Southern region reporting the highest compensation. Over the last decade, academic hospitalists received, on average, a 28%-35% lower salary, compared with community hospitalists.

Patient population and census

Lower patient encounters and compensation of the academic hospitalists poses the chicken or the egg dilemma. In the 2018 SoHM report, academic hospitalists had an average of 17% fewer encounters. Of note, AMC patients tend to have higher complexity, as measured by the Case Mix Index (CMI – the average diagnosis-related group weight of a hospital).² A higher CMI is a surrogate marker for the diagnostic diversity, clinical complexity, and resource needs of the patient population in the hospital.
 

Productivity and financial metrics

The financial bottom line is a critical aspect, and as a report in the Journal of Hospital Medicine described, all health care executives look at business metrics while making decisions.³ Below are some significant academic and community comparisons from SoHM 2018.

• Collections, encounters, and wRVUs (work relative value units) were highly correlated. All of them were lower for academic hospitalists, corroborating the fact that they see a smaller number of patients. Clinical full-time equivalents (cFTE) is a vernacular of how much of the faculty time is devoted to clinical activities. The academic data from SoHM achieves the same target, as it is standardized to 100% billable clinical activity, so the fact that many academic hospitalists do not work a full-time clinical schedule is not a factor in their lower production.
• Charges had a smaller gap likely because of sicker patients in AMCs. The higher acuity difference can also explain 12% higher wRVU/encounter for academic hospitalists.
• The wRVU/encounter ratio can indicate a few patterns: high acuity of patients in AMCs, higher levels of evaluation and management documentation, or both. As the encounters and charges have the same percentage differences, we would place our bets on the former.
• Compensation per encounter and compensation per wRVU showed that academic hospitalists do get a slight advantage.

CMI and wRVUs

Although the SoHM does not capture information on patient acuity or CMI, we speculate that the relationship between CMI and wRVUs may be more or less linear at lower levels of acuity. However, once level III E/M billing is achieved (assuming there is no critical care provided), wRVUs/encounter plateau, even as acuity continues to increase. This plateau effect may be seen more often in high-acuity AMC settings than in community hospitals.

SHM State of Hospital Medicine 2018 Report

So, in our opinion, compensation models based solely on wRVU production would not do justice for hospitalists in AMC settings since these models would fail to capture the extra work involved with very-high-acuity patients. SoHM 2018 shows the financial support per wRVU for AMC is $45.81, and for the community is $41.28, an 11% difference. We think the higher financial support per wRVU for academic practices may be related to the lost wRVU potential of caring for very-high-acuity patients.

Conclusion

In an academic setting, hospitalists are reforming the field of hospital medicine and defining the ways we could deliver care. They are the pillars of collaboration, education, research, innovation, quality, and safety. It would be increasingly crucial for academic hospitalist leaders to use comparative metrics from SoHM to advocate for their group. The bottom line can be explained by the title of the qualitative study in JHM referenced above: “Collaboration, not calculation.”³

Dr. Chadha is division chief for the division of hospital medicine at the University of Kentucky Healthcare, Lexington. He actively leads efforts of recruiting, scheduling, practice analysis, and operation of the group. He is a first-time member of the practice analysis committee. Ms. Dede is division administrator for the division of hospital medicine at the University of Kentucky Healthcare. She prepares and manages budgets, liaisons with the downstream revenue teams, and contributes to the building of academic compensation models. She is serving in the practice administrators committee for the second year and is currently vice chair of the Executive Council for the Practice Administrators special interest group.

References

1. State of Hospital Medicine Report. https://www.hospitalmedicine.org/practice-management/shms-state-of-hospital-medicine/

2. Deloitte Center for Health Solutions. Academic Medical Centers: Joining forces with community providers for broad benefits and positive outcomes. 2015. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/academic-medical-centers-consolidation.html

3. White AA et al. Collaboration, not calculation: A qualitative study of how hospital executives value hospital medicine groups. J Hosp Med. 2019;14(10):662‐7.

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 13-14, Sept. 16-17, and Oct. 7-8, 2020
2-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a 2-day, in-depth training course provided by McVey Associates.
Baltimore, Md. (Aug. 13-14); Atlanta, Ga. (Sept. 16-17); Las Vegas, Nev. (Oct. 7-8)
Aug. 15-16, 2020

2020 Principles of GI for the NP and PA

Because of COVID-19, the American Gastroenterological Association has transitioned the 2020 Principles of GI for the NP and PA course from a live meeting to a virtual course. The virtual course will provide you with team-based expert guidance on managing GI patients through case-based learning from faculty who are seasoned physicians and advanced practice providers. Register at https://bit.ly/38oeK4C.

AWARD DEADLINES

AGA-Pilot Research Award
This award provides $30,000 for 1 year to recipients at any career stage researching new directions in gastroenterology- or hepatology-related areas.
Application deadline: Sept. 2, 2020

AGA-Medtronic Pilot Research Award in Technology Innovation
This award provides $30,000 for 1 year to independent investigators at any career stage to support the research and development of novel devices or technologies that will potentially impact the diagnosis or treatment of digestive disease.
Application deadline: Sept. 2, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Celiac Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in celiac disease research.
Application deadline: Nov. 9, 2020
 

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in digestive disease research.
Application deadline: Nov. 9, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in inflammatory bowel disease (IBD) research.
Application deadline: Nov. 9, 2020
 

AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early career (i.e., 35 years or younger at the time of Digestive Disease Week^® [DDW]) basic, translational, or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
 

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week^® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb 26, 2021
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 13-14, Sept. 16-17, and Oct. 7-8, 2020
2-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a 2-day, in-depth training course provided by McVey Associates.
Baltimore, Md. (Aug. 13-14); Atlanta, Ga. (Sept. 16-17); Las Vegas, Nev. (Oct. 7-8)
Aug. 15-16, 2020

2020 Principles of GI for the NP and PA

Because of COVID-19, the American Gastroenterological Association has transitioned the 2020 Principles of GI for the NP and PA course from a live meeting to a virtual course. The virtual course will provide you with team-based expert guidance on managing GI patients through case-based learning from faculty who are seasoned physicians and advanced practice providers. Register at https://bit.ly/38oeK4C.

AWARD DEADLINES

AGA-Pilot Research Award
This award provides $30,000 for 1 year to recipients at any career stage researching new directions in gastroenterology- or hepatology-related areas.
Application deadline: Sept. 2, 2020

AGA-Medtronic Pilot Research Award in Technology Innovation
This award provides $30,000 for 1 year to independent investigators at any career stage to support the research and development of novel devices or technologies that will potentially impact the diagnosis or treatment of digestive disease.
Application deadline: Sept. 2, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Celiac Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in celiac disease research.
Application deadline: Nov. 9, 2020
 

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in digestive disease research.
Application deadline: Nov. 9, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in inflammatory bowel disease (IBD) research.
Application deadline: Nov. 9, 2020
 

AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early career (i.e., 35 years or younger at the time of Digestive Disease Week^® [DDW]) basic, translational, or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
 

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week^® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb 26, 2021
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Aug. 13-14, Sept. 16-17, and Oct. 7-8, 2020
2-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a 2-day, in-depth training course provided by McVey Associates.
Baltimore, Md. (Aug. 13-14); Atlanta, Ga. (Sept. 16-17); Las Vegas, Nev. (Oct. 7-8)
Aug. 15-16, 2020

2020 Principles of GI for the NP and PA

Because of COVID-19, the American Gastroenterological Association has transitioned the 2020 Principles of GI for the NP and PA course from a live meeting to a virtual course. The virtual course will provide you with team-based expert guidance on managing GI patients through case-based learning from faculty who are seasoned physicians and advanced practice providers. Register at https://bit.ly/38oeK4C.

AWARD DEADLINES

AGA-Pilot Research Award
This award provides $30,000 for 1 year to recipients at any career stage researching new directions in gastroenterology- or hepatology-related areas.
Application deadline: Sept. 2, 2020

AGA-Medtronic Pilot Research Award in Technology Innovation
This award provides $30,000 for 1 year to independent investigators at any career stage to support the research and development of novel devices or technologies that will potentially impact the diagnosis or treatment of digestive disease.
Application deadline: Sept. 2, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Celiac Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in celiac disease research.
Application deadline: Nov. 9, 2020
 

AGA Research Scholar Award (RSA)
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in digestive disease research.
Application deadline: Nov. 9, 2020
 

AGA–Takeda Pharmaceuticals Research Scholar Award in Inflammatory Bowel Disease
This award provides $100,000 per year for 3 years (totaling $300,000) to early-career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in inflammatory bowel disease (IBD) research.
Application deadline: Nov. 9, 2020
 

AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early career (i.e., 35 years or younger at the time of Digestive Disease Week^® [DDW]) basic, translational, or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
 

AGA Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students, or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week^® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb 26, 2021
 

AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021