On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.¹ The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).

The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.² The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.² All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.

Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.^2,3 All those with TTS have been hospitalized, and 9 have died.^2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.

The significance of the recommendation:

• Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
• The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
• The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
• The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.

The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.

The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.

On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.¹ The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).

The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.² The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.² All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.

Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.^2,3 All those with TTS have been hospitalized, and 9 have died.^2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.

The significance of the recommendation:

• Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
• The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
• The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
• The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.

The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.

The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.

On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.¹ The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).

The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.² The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.² All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.

Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.^2,3 All those with TTS have been hospitalized, and 9 have died.^2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.

The significance of the recommendation:

• Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
• The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
• The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
• The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.

The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.

The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

For the first time, researchers have analyzed oropharyngeal cancer trends in all 50 states and Washington, D.C., and the cross-sectional study shows the condition is increasingly common among older men. The researchers also found an increase in the proportion of regional stage oropharyngeal cancer (3.1% per year in men, 1.0% in women) and mortality among men (2.1% per year).

There were also significantly higher rates of oropharyngeal cancer in Midwestern and Southeastern states, suggesting a need for improved prevention efforts. In addition to older men, an increasing number of people with oropharyngeal cancer are immunosuppressed patients who, like older men, present with advanced tumors.

The new data present a picture of an evolving landscape. “Fifteen or 20 years ago, the increase was largely occurring among young individuals, but now, it has shifted. In our study, we found the most rapid rise now is among men aged 65 years and older, and a rise in mortality as a result of these increases,” said lead author Ashish A. Deshmukh, PhD, MPH, an assistant professor of health services, research, management, and policy at the University of Florida, Gainesville.

The Southeast and Midwest aren’t just hotspots for men. Although the incidence was lower among women overall, the Southeast and Midwest saw greater increases.

The study, published Dec. 16, 2021, in JAMA Otolaryngology – Head & Neck Surgery, also hints that the human papillomavirus (HPV) vaccine, first introduced in 2006, may be having an impact on oropharyngeal cancer incidence. When the researchers stratified incidence by age group, they found a decline among individuals younger than 45 from 2008 to 2017 of 2.1% per year. “It might be still quite early to say that the decrease is driven by HPV vaccination, but we are starting to see a decrease in oropharyngeal cancer incidence among the youngest age group, which is likely to benefit from HPV vaccination earliest,” Dr. Deshmukh said in an interview.

The researchers examined data on 260,182 oropharyngeal cancer cases from the U.S. Cancer Statistics data set from 2001 to 2017. About 80% of cases were in men, and 54% occurred in Southeastern (32%) or Midwestern states (22%). Overall, there was a 2.7% annual increase in oropharyngeal cancer nationally among men, and 0.5% among women. Increases were highest among men in states in the Southeast and Midwest regions, and a similar trend was seen among women with a greater than 2% increase per year. Mortality increased 2.1% per year among men between 2006 and 2017, but declined by 1.2% in women.

According to Nosayaba Osazuwa-Peters, PhD, of Duke University, Durham, N.C., and Louise Davies, MD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., the study leads to cautious optimism that the HPV vaccine may be having an effect on oropharyngeal cancer incidence in young men. Still, unvaccinated older individuals will remain vulnerable. “This makes the recent extension of the age of eligibility for HPV vaccination to age 45 years a critical advance. The more adults up to the age of 45 years who get vaccinated now, the more benefit we will see from their vaccination in the next 2 or more decades. We need to ring out this message loud and clear as head and neck cancer clinicians,” they wrote in an accompanying editorial.

The study was limited in part by the fact that U.S. cancer registry data has no information on risk factors.

The study was funded by the National Cancer Institute and the National Institutes of Health.

For the first time, researchers have analyzed oropharyngeal cancer trends in all 50 states and Washington, D.C., and the cross-sectional study shows the condition is increasingly common among older men. The researchers also found an increase in the proportion of regional stage oropharyngeal cancer (3.1% per year in men, 1.0% in women) and mortality among men (2.1% per year).

There were also significantly higher rates of oropharyngeal cancer in Midwestern and Southeastern states, suggesting a need for improved prevention efforts. In addition to older men, an increasing number of people with oropharyngeal cancer are immunosuppressed patients who, like older men, present with advanced tumors.

The new data present a picture of an evolving landscape. “Fifteen or 20 years ago, the increase was largely occurring among young individuals, but now, it has shifted. In our study, we found the most rapid rise now is among men aged 65 years and older, and a rise in mortality as a result of these increases,” said lead author Ashish A. Deshmukh, PhD, MPH, an assistant professor of health services, research, management, and policy at the University of Florida, Gainesville.

The Southeast and Midwest aren’t just hotspots for men. Although the incidence was lower among women overall, the Southeast and Midwest saw greater increases.

The study, published Dec. 16, 2021, in JAMA Otolaryngology – Head & Neck Surgery, also hints that the human papillomavirus (HPV) vaccine, first introduced in 2006, may be having an impact on oropharyngeal cancer incidence. When the researchers stratified incidence by age group, they found a decline among individuals younger than 45 from 2008 to 2017 of 2.1% per year. “It might be still quite early to say that the decrease is driven by HPV vaccination, but we are starting to see a decrease in oropharyngeal cancer incidence among the youngest age group, which is likely to benefit from HPV vaccination earliest,” Dr. Deshmukh said in an interview.

The researchers examined data on 260,182 oropharyngeal cancer cases from the U.S. Cancer Statistics data set from 2001 to 2017. About 80% of cases were in men, and 54% occurred in Southeastern (32%) or Midwestern states (22%). Overall, there was a 2.7% annual increase in oropharyngeal cancer nationally among men, and 0.5% among women. Increases were highest among men in states in the Southeast and Midwest regions, and a similar trend was seen among women with a greater than 2% increase per year. Mortality increased 2.1% per year among men between 2006 and 2017, but declined by 1.2% in women.

According to Nosayaba Osazuwa-Peters, PhD, of Duke University, Durham, N.C., and Louise Davies, MD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., the study leads to cautious optimism that the HPV vaccine may be having an effect on oropharyngeal cancer incidence in young men. Still, unvaccinated older individuals will remain vulnerable. “This makes the recent extension of the age of eligibility for HPV vaccination to age 45 years a critical advance. The more adults up to the age of 45 years who get vaccinated now, the more benefit we will see from their vaccination in the next 2 or more decades. We need to ring out this message loud and clear as head and neck cancer clinicians,” they wrote in an accompanying editorial.

The study was limited in part by the fact that U.S. cancer registry data has no information on risk factors.

The study was funded by the National Cancer Institute and the National Institutes of Health.

For the first time, researchers have analyzed oropharyngeal cancer trends in all 50 states and Washington, D.C., and the cross-sectional study shows the condition is increasingly common among older men. The researchers also found an increase in the proportion of regional stage oropharyngeal cancer (3.1% per year in men, 1.0% in women) and mortality among men (2.1% per year).

There were also significantly higher rates of oropharyngeal cancer in Midwestern and Southeastern states, suggesting a need for improved prevention efforts. In addition to older men, an increasing number of people with oropharyngeal cancer are immunosuppressed patients who, like older men, present with advanced tumors.

The new data present a picture of an evolving landscape. “Fifteen or 20 years ago, the increase was largely occurring among young individuals, but now, it has shifted. In our study, we found the most rapid rise now is among men aged 65 years and older, and a rise in mortality as a result of these increases,” said lead author Ashish A. Deshmukh, PhD, MPH, an assistant professor of health services, research, management, and policy at the University of Florida, Gainesville.

The Southeast and Midwest aren’t just hotspots for men. Although the incidence was lower among women overall, the Southeast and Midwest saw greater increases.

The study, published Dec. 16, 2021, in JAMA Otolaryngology – Head & Neck Surgery, also hints that the human papillomavirus (HPV) vaccine, first introduced in 2006, may be having an impact on oropharyngeal cancer incidence. When the researchers stratified incidence by age group, they found a decline among individuals younger than 45 from 2008 to 2017 of 2.1% per year. “It might be still quite early to say that the decrease is driven by HPV vaccination, but we are starting to see a decrease in oropharyngeal cancer incidence among the youngest age group, which is likely to benefit from HPV vaccination earliest,” Dr. Deshmukh said in an interview.

The researchers examined data on 260,182 oropharyngeal cancer cases from the U.S. Cancer Statistics data set from 2001 to 2017. About 80% of cases were in men, and 54% occurred in Southeastern (32%) or Midwestern states (22%). Overall, there was a 2.7% annual increase in oropharyngeal cancer nationally among men, and 0.5% among women. Increases were highest among men in states in the Southeast and Midwest regions, and a similar trend was seen among women with a greater than 2% increase per year. Mortality increased 2.1% per year among men between 2006 and 2017, but declined by 1.2% in women.

According to Nosayaba Osazuwa-Peters, PhD, of Duke University, Durham, N.C., and Louise Davies, MD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., the study leads to cautious optimism that the HPV vaccine may be having an effect on oropharyngeal cancer incidence in young men. Still, unvaccinated older individuals will remain vulnerable. “This makes the recent extension of the age of eligibility for HPV vaccination to age 45 years a critical advance. The more adults up to the age of 45 years who get vaccinated now, the more benefit we will see from their vaccination in the next 2 or more decades. We need to ring out this message loud and clear as head and neck cancer clinicians,” they wrote in an accompanying editorial.

The study was limited in part by the fact that U.S. cancer registry data has no information on risk factors.

The study was funded by the National Cancer Institute and the National Institutes of Health.

A new era of evidence-based practice for atopic dermatitis

Atopic dermatitis (AD) is one of the most common diseases of childhood and still very common in adults worldwide. AD is also a very burdensome disease with considerable patient-burden. Despite the enormous population- and patient- burden, there remain many unmet needs in the management of AD. In addition, many treatments commonly used in AD had scant or mixed evidence regarding their efficacy and safety. For example, topical corticosteroids (TCS) are the workhorse for treatment in AD and most other inflammatory skin diseases. Yet, virtually everything we know about the efficacy of TCS comes from vasoconstriction proxy assays with almost no studies formally studying the efficacy of TCS in AD. Similarly, many therapies used off-label to treat more severe AD, such as phototherapy or allergen immunotherapy have inconsistent evidence to guide their use. Well, things are finally changing and the evidence is coming in at a frenzied pace. Development of multiple novel therapeutics in AD led to renewed interest in studying the efficacy and safety of older therapies as well.

• Phototherapy is an important treatment modality in AD patients who have an inadequate response to topical therapy. Many different modalities and devices were used to treat AD over the years, including narrowband ultraviolet B (NBUVB) and ultraviolet A (UVA)-1. NBUVB is the most commonly used approach in the United States and some other regions of the world. Ben Mordehai et al. published the results of a retrospective cohort study of 390 Israeli patients with moderate-severe AD treated with NBUVB therapy between 2000-2017 with ≥3 years of follow-up. Overall, 55.4% achieved an Investigator’s Global Assessment score of clear or almost clear. Facial involvement, occurrence of adverse effects, fewer treatments, and pretreatment immunoglobulin E levels >4000 IU/ml were associated with poorer clinical response to NBUVB. Median duration of response was 12 months with more relapses in children (<18 years).

• House dust mites (HDM) were previously shown to be triggers of AD via Immunoglobulin E dependent and independent mechanisms. Unfortunately, HDM avoidance is challenging for patients and has not proven to be reliably effective in clinical trials. Previous studies examined different approaches for immunotherapy to HDM with mixed results. Langer et al. published the results of a randomized, double-blind, placebo-controlled trial of HDM sublingual immunotherapy (SLIT) or placebo for 18 months in 91 children and adults with AD and positive skin test result and/or Immunoglobulin E to Dermatophagoides pteronyssinus. After 18 months, patients treated with HDM SLIT achieved greater reductions in the SCOring AD (SCORAD) index and were more likely to achieve an Investigator’s Global Assessment score of clear or almost clear compared to placebo. Headache and abdominal pain were the most common adverse events reported by both groups. Efficacy of HDM SLIT in this study was relatively modest. Nevertheless, it appears to be a safe therapy and a reasonable adjunctive therapy in patients with AD whose disease is believed to be triggered by HDM.

• We are fortunate to have multiple non-steroidal topical therapies for atopic dermatitis, including crisaborole ointment, pimecrolimus cream and tacrolimus ointment. A number of questions remain about how these therapies compare with each other and with topical corticosteroids.  Some of these questions were answered in two recent studies.
  • Thom et al. compared individual data from two phase 3 studies of crisaborole ointment with previously published data for topical pimecrolimus and tacrolimus in patients ≥2 years with mild-to-moderate AD using an approach referred to as unanchored matching-adjusted indirect comparison. By week 6, the odds of achieving Investigator’s Static Global Assessment score of 0/1 was higher for crisaborole ointment vs. pimecrolimus cream and tacrolimus 0.03% ointment.
  • Salava et al. followed 152 children age 1-3 years with moderate-severe AD for 36 months. They found no significant differences of topical tacrolimus 0.03% or 0.1% ointment vs. low or mid potency topical corticosteroids on AD severity (as judged by the eczema area and severity index), skin or other infections, and various cytokine levels.

While these data do not replace the need for head-to-head studies, they do provide important context about comparative efficacy and safety of the various topical agents in our toolbox.

References

1. Ben Mordehai Y et al. Long-Term Narrowband UV-B Efficacy in Moderate to Severe Atopic Dermatitis. Dermatitis. 2021 (Nov 27).
2. Langer SS et al. Efficacy of house dust mite sublingual immunotherapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol Pract. 2021 (Nov 9).
3. Thom H et al. Matching-Adjusted Indirect Comparison of Crisaborole Ointment 2% vs. Topical Calcineurin Inhibitors in the Treatment of Patients with Mild-to-Moderate Atopic Dermatitis Dermatol Ther (Heidelb). 2021 (Dec 8).
4. Salava A et al. Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis - a 36-month follow-up study. Clin Exp Dermatol. 2021 (Nov 19).

A new era of evidence-based practice for atopic dermatitis

Atopic dermatitis (AD) is one of the most common diseases of childhood and still very common in adults worldwide. AD is also a very burdensome disease with considerable patient-burden. Despite the enormous population- and patient- burden, there remain many unmet needs in the management of AD. In addition, many treatments commonly used in AD had scant or mixed evidence regarding their efficacy and safety. For example, topical corticosteroids (TCS) are the workhorse for treatment in AD and most other inflammatory skin diseases. Yet, virtually everything we know about the efficacy of TCS comes from vasoconstriction proxy assays with almost no studies formally studying the efficacy of TCS in AD. Similarly, many therapies used off-label to treat more severe AD, such as phototherapy or allergen immunotherapy have inconsistent evidence to guide their use. Well, things are finally changing and the evidence is coming in at a frenzied pace. Development of multiple novel therapeutics in AD led to renewed interest in studying the efficacy and safety of older therapies as well.

• Phototherapy is an important treatment modality in AD patients who have an inadequate response to topical therapy. Many different modalities and devices were used to treat AD over the years, including narrowband ultraviolet B (NBUVB) and ultraviolet A (UVA)-1. NBUVB is the most commonly used approach in the United States and some other regions of the world. Ben Mordehai et al. published the results of a retrospective cohort study of 390 Israeli patients with moderate-severe AD treated with NBUVB therapy between 2000-2017 with ≥3 years of follow-up. Overall, 55.4% achieved an Investigator’s Global Assessment score of clear or almost clear. Facial involvement, occurrence of adverse effects, fewer treatments, and pretreatment immunoglobulin E levels >4000 IU/ml were associated with poorer clinical response to NBUVB. Median duration of response was 12 months with more relapses in children (<18 years).

• House dust mites (HDM) were previously shown to be triggers of AD via Immunoglobulin E dependent and independent mechanisms. Unfortunately, HDM avoidance is challenging for patients and has not proven to be reliably effective in clinical trials. Previous studies examined different approaches for immunotherapy to HDM with mixed results. Langer et al. published the results of a randomized, double-blind, placebo-controlled trial of HDM sublingual immunotherapy (SLIT) or placebo for 18 months in 91 children and adults with AD and positive skin test result and/or Immunoglobulin E to Dermatophagoides pteronyssinus. After 18 months, patients treated with HDM SLIT achieved greater reductions in the SCOring AD (SCORAD) index and were more likely to achieve an Investigator’s Global Assessment score of clear or almost clear compared to placebo. Headache and abdominal pain were the most common adverse events reported by both groups. Efficacy of HDM SLIT in this study was relatively modest. Nevertheless, it appears to be a safe therapy and a reasonable adjunctive therapy in patients with AD whose disease is believed to be triggered by HDM.

• We are fortunate to have multiple non-steroidal topical therapies for atopic dermatitis, including crisaborole ointment, pimecrolimus cream and tacrolimus ointment. A number of questions remain about how these therapies compare with each other and with topical corticosteroids.  Some of these questions were answered in two recent studies.
  • Thom et al. compared individual data from two phase 3 studies of crisaborole ointment with previously published data for topical pimecrolimus and tacrolimus in patients ≥2 years with mild-to-moderate AD using an approach referred to as unanchored matching-adjusted indirect comparison. By week 6, the odds of achieving Investigator’s Static Global Assessment score of 0/1 was higher for crisaborole ointment vs. pimecrolimus cream and tacrolimus 0.03% ointment.
  • Salava et al. followed 152 children age 1-3 years with moderate-severe AD for 36 months. They found no significant differences of topical tacrolimus 0.03% or 0.1% ointment vs. low or mid potency topical corticosteroids on AD severity (as judged by the eczema area and severity index), skin or other infections, and various cytokine levels.

While these data do not replace the need for head-to-head studies, they do provide important context about comparative efficacy and safety of the various topical agents in our toolbox.

References

1. Ben Mordehai Y et al. Long-Term Narrowband UV-B Efficacy in Moderate to Severe Atopic Dermatitis. Dermatitis. 2021 (Nov 27).
2. Langer SS et al. Efficacy of house dust mite sublingual immunotherapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol Pract. 2021 (Nov 9).
3. Thom H et al. Matching-Adjusted Indirect Comparison of Crisaborole Ointment 2% vs. Topical Calcineurin Inhibitors in the Treatment of Patients with Mild-to-Moderate Atopic Dermatitis Dermatol Ther (Heidelb). 2021 (Dec 8).
4. Salava A et al. Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis - a 36-month follow-up study. Clin Exp Dermatol. 2021 (Nov 19).

A new era of evidence-based practice for atopic dermatitis

Atopic dermatitis (AD) is one of the most common diseases of childhood and still very common in adults worldwide. AD is also a very burdensome disease with considerable patient-burden. Despite the enormous population- and patient- burden, there remain many unmet needs in the management of AD. In addition, many treatments commonly used in AD had scant or mixed evidence regarding their efficacy and safety. For example, topical corticosteroids (TCS) are the workhorse for treatment in AD and most other inflammatory skin diseases. Yet, virtually everything we know about the efficacy of TCS comes from vasoconstriction proxy assays with almost no studies formally studying the efficacy of TCS in AD. Similarly, many therapies used off-label to treat more severe AD, such as phototherapy or allergen immunotherapy have inconsistent evidence to guide their use. Well, things are finally changing and the evidence is coming in at a frenzied pace. Development of multiple novel therapeutics in AD led to renewed interest in studying the efficacy and safety of older therapies as well.

• Phototherapy is an important treatment modality in AD patients who have an inadequate response to topical therapy. Many different modalities and devices were used to treat AD over the years, including narrowband ultraviolet B (NBUVB) and ultraviolet A (UVA)-1. NBUVB is the most commonly used approach in the United States and some other regions of the world. Ben Mordehai et al. published the results of a retrospective cohort study of 390 Israeli patients with moderate-severe AD treated with NBUVB therapy between 2000-2017 with ≥3 years of follow-up. Overall, 55.4% achieved an Investigator’s Global Assessment score of clear or almost clear. Facial involvement, occurrence of adverse effects, fewer treatments, and pretreatment immunoglobulin E levels >4000 IU/ml were associated with poorer clinical response to NBUVB. Median duration of response was 12 months with more relapses in children (<18 years).

• House dust mites (HDM) were previously shown to be triggers of AD via Immunoglobulin E dependent and independent mechanisms. Unfortunately, HDM avoidance is challenging for patients and has not proven to be reliably effective in clinical trials. Previous studies examined different approaches for immunotherapy to HDM with mixed results. Langer et al. published the results of a randomized, double-blind, placebo-controlled trial of HDM sublingual immunotherapy (SLIT) or placebo for 18 months in 91 children and adults with AD and positive skin test result and/or Immunoglobulin E to Dermatophagoides pteronyssinus. After 18 months, patients treated with HDM SLIT achieved greater reductions in the SCOring AD (SCORAD) index and were more likely to achieve an Investigator’s Global Assessment score of clear or almost clear compared to placebo. Headache and abdominal pain were the most common adverse events reported by both groups. Efficacy of HDM SLIT in this study was relatively modest. Nevertheless, it appears to be a safe therapy and a reasonable adjunctive therapy in patients with AD whose disease is believed to be triggered by HDM.

• We are fortunate to have multiple non-steroidal topical therapies for atopic dermatitis, including crisaborole ointment, pimecrolimus cream and tacrolimus ointment. A number of questions remain about how these therapies compare with each other and with topical corticosteroids.  Some of these questions were answered in two recent studies.
  • Thom et al. compared individual data from two phase 3 studies of crisaborole ointment with previously published data for topical pimecrolimus and tacrolimus in patients ≥2 years with mild-to-moderate AD using an approach referred to as unanchored matching-adjusted indirect comparison. By week 6, the odds of achieving Investigator’s Static Global Assessment score of 0/1 was higher for crisaborole ointment vs. pimecrolimus cream and tacrolimus 0.03% ointment.
  • Salava et al. followed 152 children age 1-3 years with moderate-severe AD for 36 months. They found no significant differences of topical tacrolimus 0.03% or 0.1% ointment vs. low or mid potency topical corticosteroids on AD severity (as judged by the eczema area and severity index), skin or other infections, and various cytokine levels.

While these data do not replace the need for head-to-head studies, they do provide important context about comparative efficacy and safety of the various topical agents in our toolbox.

References

1. Ben Mordehai Y et al. Long-Term Narrowband UV-B Efficacy in Moderate to Severe Atopic Dermatitis. Dermatitis. 2021 (Nov 27).
2. Langer SS et al. Efficacy of house dust mite sublingual immunotherapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol Pract. 2021 (Nov 9).
3. Thom H et al. Matching-Adjusted Indirect Comparison of Crisaborole Ointment 2% vs. Topical Calcineurin Inhibitors in the Treatment of Patients with Mild-to-Moderate Atopic Dermatitis Dermatol Ther (Heidelb). 2021 (Dec 8).
4. Salava A et al. Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis - a 36-month follow-up study. Clin Exp Dermatol. 2021 (Nov 19).

The practitioner’s primary responsibility in managing respiratory infection is to determine which patients with community acquired pneumonia (CAP) warrant hospitalization and more aggressive management. Standard practice for mild infection dictates empiric administration of 5 days of antimicrobial agents¹ particularly for the youngest, oldest and patients with underlying comorbid conditions, usually on an outpatient basis with careful follow-up.

Variables for hospitalization and for the selection of antibiotic therapy include the likelihood of a bacterial etiology, epidemiologic considerations, clinical symptoms, predisposing host factors, age, and radiographic findings. Patients who have viral processes generally have low-grade fever and are usually uncomfortable, although they may not appear toxic. However, it is not possible to distinguish between viral and bacterial pneumonia on clinical grounds alone, particularly with the emergence of COVID-19 (SARS-CoV-2), as rapid progression of an initially mild viral upper respiratory infection may become life threatening, particularly in patients with comorbid conditions, such as pulmonary disease, diabetes, and immunodeficiency. All patients with severe CAP should be tested for this viral agent. A recent study of 96 patients with chronic obstructive pulmonary disease (COPD) and COVID-19 infection showed they had higher intensive care unit (ICU) admissions, ventilation requirements, cardiovascular events, and mortality as compared to 1,129 hospitalized patients with COPD and non-COVID-19 infection.² In addition to COVID-19, type 2 diabetes mellitus must also be considered, as such patients developing severe CAP from all causes have a higher mortality and poorer clinical outcomes than those without diabetes.³

      Predicting which patients are likely to progress to severe disease from CAP is a challenging task. In the past clinicians relied on clinical assessment, along with some inflammatory lab studies such as the complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin. Newer tests have recently been studied for their ability to inform prognosis and likely mortality. A very simple test is the admission blood glucose level, which, if increased at hospital admission, is associated with a higher mortality.⁴ More recently the quick sequential organ failure assessment (qSOFA) score was shown to be better than the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria score in predicting mortality.⁵ A potential new laboratory test, serum IL-17 concentrations, demonstrated a positive correlation with CAP severity, ICU admission, longer hospital stay, mechanical ventilation, and mortality.⁶

Current studies have identified some potential advantages of newer antibiotics. Cefoperazone-sulbactam was shown to be equivalent to piperacillin-tazobactam (PIP-TAZO) for treating severe CAP in elderly patients, thereby avoiding the potential acute kidney injury (AKI) of the PIP-TAZO – vancomycin combination.⁷ This benefit of reduced AKI was supported by a retrospective cohort study that included 449,535 hospitalized adult patients with CAP.⁸

In a phase 3 study, lefamulin was as effective as moxifloxacin in treating bacterial CAP, including drug-resistant strains and typical, atypical, and polymicrobial infections.⁹  Of 1,289 study patients, a pathogen was identified in 709. Side effects were minor. This antibiotic has a unique mechanism of action through inhibition of protein synthesis, preventing the binding of transfer RNA.

Adjunctive oral dexamethasone therapy for CAP has been advocated by some experts. In a study of 354 non-ICU patients, a shorter hospital stay was seen in patients who received dexamethasone vs. placebo (4 vs. 6 days) but only in patients who had elevated neutrophil or WBC counts, or high neutrophil-lymphocyte ratios; otherwise there was no difference.¹⁰

References

1. Vaughn VM et al. a statewide collaborative quality initiative to improve antibiotic duration and outcomes in patients hospitalized with uncomplicated community-acquired pneumonia. Clin Infect Dis. 2021(Nov 13):ciab950 (Nov 13). 
2. Sheikh D et al. Clinical outcomes in patients with COPD hospitalized with SARS-CoV-2 versus non-SARS-CoV-2 community-acquired pneumonia. Respir Med. 2021(Dec 8);191:106714.
3. Huang D et al. Clinical characteristics and risk factors associated with mortality in patients with severe community-acquired pneumonia and type 2 diabetes mellitus. Crit Care. 2021(Dec 7);25:419.
4. Shen Y et al. Association of admission blood glucose level with all-cause mortality according to age in patients with community acquired pneumonia. Int J Gen Med. 2021(Nov 6);14:7775-7781.
5. Guo Q et al. qSOFA predicted pneumonia mortality better than minor criteria and worse than CURB-65 with robust elements and higher convergence. Am J Emerg Med. 2022(Feb);52:1-7.
6. Feng CM et al. Serum interleukin-17 predicts severity and prognosis in patients with community acquired pneumonia: a prospective cohort study. BMC Pulm Med. 2021(Dec 2);21:393.
7. Huang CT et al. Clinical effectiveness of cefoperazone-sulbactam versus piperacillin-tazobactam for the treatment of pneumonia in the elderly population. Int J Antimicrob Agents. 2021(Dec 4);106491.
8. Le P et al. Association of antibiotic use and acute kidney injury in patients hospitalized with community-acquired pneumonia. Curr Med Res Opin. 2021 (Nov 15).   
9. Paukner S et al. Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin. J Glob Antimicrob Resist. 2021 (Nov 14).
10. Wittermans E et al. Neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio in relation to response to adjunctive dexamethasone treatment in community-acquired pneumonia. Eur J Intern Med. 2021 (Nov 12).

The practitioner’s primary responsibility in managing respiratory infection is to determine which patients with community acquired pneumonia (CAP) warrant hospitalization and more aggressive management. Standard practice for mild infection dictates empiric administration of 5 days of antimicrobial agents¹ particularly for the youngest, oldest and patients with underlying comorbid conditions, usually on an outpatient basis with careful follow-up.

Variables for hospitalization and for the selection of antibiotic therapy include the likelihood of a bacterial etiology, epidemiologic considerations, clinical symptoms, predisposing host factors, age, and radiographic findings. Patients who have viral processes generally have low-grade fever and are usually uncomfortable, although they may not appear toxic. However, it is not possible to distinguish between viral and bacterial pneumonia on clinical grounds alone, particularly with the emergence of COVID-19 (SARS-CoV-2), as rapid progression of an initially mild viral upper respiratory infection may become life threatening, particularly in patients with comorbid conditions, such as pulmonary disease, diabetes, and immunodeficiency. All patients with severe CAP should be tested for this viral agent. A recent study of 96 patients with chronic obstructive pulmonary disease (COPD) and COVID-19 infection showed they had higher intensive care unit (ICU) admissions, ventilation requirements, cardiovascular events, and mortality as compared to 1,129 hospitalized patients with COPD and non-COVID-19 infection.² In addition to COVID-19, type 2 diabetes mellitus must also be considered, as such patients developing severe CAP from all causes have a higher mortality and poorer clinical outcomes than those without diabetes.³

      Predicting which patients are likely to progress to severe disease from CAP is a challenging task. In the past clinicians relied on clinical assessment, along with some inflammatory lab studies such as the complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin. Newer tests have recently been studied for their ability to inform prognosis and likely mortality. A very simple test is the admission blood glucose level, which, if increased at hospital admission, is associated with a higher mortality.⁴ More recently the quick sequential organ failure assessment (qSOFA) score was shown to be better than the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria score in predicting mortality.⁵ A potential new laboratory test, serum IL-17 concentrations, demonstrated a positive correlation with CAP severity, ICU admission, longer hospital stay, mechanical ventilation, and mortality.⁶

Current studies have identified some potential advantages of newer antibiotics. Cefoperazone-sulbactam was shown to be equivalent to piperacillin-tazobactam (PIP-TAZO) for treating severe CAP in elderly patients, thereby avoiding the potential acute kidney injury (AKI) of the PIP-TAZO – vancomycin combination.⁷ This benefit of reduced AKI was supported by a retrospective cohort study that included 449,535 hospitalized adult patients with CAP.⁸

In a phase 3 study, lefamulin was as effective as moxifloxacin in treating bacterial CAP, including drug-resistant strains and typical, atypical, and polymicrobial infections.⁹  Of 1,289 study patients, a pathogen was identified in 709. Side effects were minor. This antibiotic has a unique mechanism of action through inhibition of protein synthesis, preventing the binding of transfer RNA.

Adjunctive oral dexamethasone therapy for CAP has been advocated by some experts. In a study of 354 non-ICU patients, a shorter hospital stay was seen in patients who received dexamethasone vs. placebo (4 vs. 6 days) but only in patients who had elevated neutrophil or WBC counts, or high neutrophil-lymphocyte ratios; otherwise there was no difference.¹⁰

References

1. Vaughn VM et al. a statewide collaborative quality initiative to improve antibiotic duration and outcomes in patients hospitalized with uncomplicated community-acquired pneumonia. Clin Infect Dis. 2021(Nov 13):ciab950 (Nov 13). 
2. Sheikh D et al. Clinical outcomes in patients with COPD hospitalized with SARS-CoV-2 versus non-SARS-CoV-2 community-acquired pneumonia. Respir Med. 2021(Dec 8);191:106714.
3. Huang D et al. Clinical characteristics and risk factors associated with mortality in patients with severe community-acquired pneumonia and type 2 diabetes mellitus. Crit Care. 2021(Dec 7);25:419.
4. Shen Y et al. Association of admission blood glucose level with all-cause mortality according to age in patients with community acquired pneumonia. Int J Gen Med. 2021(Nov 6);14:7775-7781.
5. Guo Q et al. qSOFA predicted pneumonia mortality better than minor criteria and worse than CURB-65 with robust elements and higher convergence. Am J Emerg Med. 2022(Feb);52:1-7.
6. Feng CM et al. Serum interleukin-17 predicts severity and prognosis in patients with community acquired pneumonia: a prospective cohort study. BMC Pulm Med. 2021(Dec 2);21:393.
7. Huang CT et al. Clinical effectiveness of cefoperazone-sulbactam versus piperacillin-tazobactam for the treatment of pneumonia in the elderly population. Int J Antimicrob Agents. 2021(Dec 4);106491.
8. Le P et al. Association of antibiotic use and acute kidney injury in patients hospitalized with community-acquired pneumonia. Curr Med Res Opin. 2021 (Nov 15).   
9. Paukner S et al. Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin. J Glob Antimicrob Resist. 2021 (Nov 14).
10. Wittermans E et al. Neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio in relation to response to adjunctive dexamethasone treatment in community-acquired pneumonia. Eur J Intern Med. 2021 (Nov 12).

The practitioner’s primary responsibility in managing respiratory infection is to determine which patients with community acquired pneumonia (CAP) warrant hospitalization and more aggressive management. Standard practice for mild infection dictates empiric administration of 5 days of antimicrobial agents¹ particularly for the youngest, oldest and patients with underlying comorbid conditions, usually on an outpatient basis with careful follow-up.

Variables for hospitalization and for the selection of antibiotic therapy include the likelihood of a bacterial etiology, epidemiologic considerations, clinical symptoms, predisposing host factors, age, and radiographic findings. Patients who have viral processes generally have low-grade fever and are usually uncomfortable, although they may not appear toxic. However, it is not possible to distinguish between viral and bacterial pneumonia on clinical grounds alone, particularly with the emergence of COVID-19 (SARS-CoV-2), as rapid progression of an initially mild viral upper respiratory infection may become life threatening, particularly in patients with comorbid conditions, such as pulmonary disease, diabetes, and immunodeficiency. All patients with severe CAP should be tested for this viral agent. A recent study of 96 patients with chronic obstructive pulmonary disease (COPD) and COVID-19 infection showed they had higher intensive care unit (ICU) admissions, ventilation requirements, cardiovascular events, and mortality as compared to 1,129 hospitalized patients with COPD and non-COVID-19 infection.² In addition to COVID-19, type 2 diabetes mellitus must also be considered, as such patients developing severe CAP from all causes have a higher mortality and poorer clinical outcomes than those without diabetes.³

      Predicting which patients are likely to progress to severe disease from CAP is a challenging task. In the past clinicians relied on clinical assessment, along with some inflammatory lab studies such as the complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin. Newer tests have recently been studied for their ability to inform prognosis and likely mortality. A very simple test is the admission blood glucose level, which, if increased at hospital admission, is associated with a higher mortality.⁴ More recently the quick sequential organ failure assessment (qSOFA) score was shown to be better than the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria score in predicting mortality.⁵ A potential new laboratory test, serum IL-17 concentrations, demonstrated a positive correlation with CAP severity, ICU admission, longer hospital stay, mechanical ventilation, and mortality.⁶

Current studies have identified some potential advantages of newer antibiotics. Cefoperazone-sulbactam was shown to be equivalent to piperacillin-tazobactam (PIP-TAZO) for treating severe CAP in elderly patients, thereby avoiding the potential acute kidney injury (AKI) of the PIP-TAZO – vancomycin combination.⁷ This benefit of reduced AKI was supported by a retrospective cohort study that included 449,535 hospitalized adult patients with CAP.⁸

In a phase 3 study, lefamulin was as effective as moxifloxacin in treating bacterial CAP, including drug-resistant strains and typical, atypical, and polymicrobial infections.⁹  Of 1,289 study patients, a pathogen was identified in 709. Side effects were minor. This antibiotic has a unique mechanism of action through inhibition of protein synthesis, preventing the binding of transfer RNA.

Adjunctive oral dexamethasone therapy for CAP has been advocated by some experts. In a study of 354 non-ICU patients, a shorter hospital stay was seen in patients who received dexamethasone vs. placebo (4 vs. 6 days) but only in patients who had elevated neutrophil or WBC counts, or high neutrophil-lymphocyte ratios; otherwise there was no difference.¹⁰

References

1. Vaughn VM et al. a statewide collaborative quality initiative to improve antibiotic duration and outcomes in patients hospitalized with uncomplicated community-acquired pneumonia. Clin Infect Dis. 2021(Nov 13):ciab950 (Nov 13). 
2. Sheikh D et al. Clinical outcomes in patients with COPD hospitalized with SARS-CoV-2 versus non-SARS-CoV-2 community-acquired pneumonia. Respir Med. 2021(Dec 8);191:106714.
3. Huang D et al. Clinical characteristics and risk factors associated with mortality in patients with severe community-acquired pneumonia and type 2 diabetes mellitus. Crit Care. 2021(Dec 7);25:419.
4. Shen Y et al. Association of admission blood glucose level with all-cause mortality according to age in patients with community acquired pneumonia. Int J Gen Med. 2021(Nov 6);14:7775-7781.
5. Guo Q et al. qSOFA predicted pneumonia mortality better than minor criteria and worse than CURB-65 with robust elements and higher convergence. Am J Emerg Med. 2022(Feb);52:1-7.
6. Feng CM et al. Serum interleukin-17 predicts severity and prognosis in patients with community acquired pneumonia: a prospective cohort study. BMC Pulm Med. 2021(Dec 2);21:393.
7. Huang CT et al. Clinical effectiveness of cefoperazone-sulbactam versus piperacillin-tazobactam for the treatment of pneumonia in the elderly population. Int J Antimicrob Agents. 2021(Dec 4);106491.
8. Le P et al. Association of antibiotic use and acute kidney injury in patients hospitalized with community-acquired pneumonia. Curr Med Res Opin. 2021 (Nov 15).   
9. Paukner S et al. Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin. J Glob Antimicrob Resist. 2021 (Nov 14).
10. Wittermans E et al. Neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio in relation to response to adjunctive dexamethasone treatment in community-acquired pneumonia. Eur J Intern Med. 2021 (Nov 12).

Modern efforts to monitor and improve quality in health care can trace their roots to the early 20th century. At that time, hospitals initiated mechanisms to ensure standard practices for privileging clinicians, reporting medical records and clinical data, and establishing supervised diagnostic facilities. Years later, Avedis Donabedian published “Evaluating the Quality of Medical Care,” which outlined how health care should be measured across three areas – structure, process, and outcome – and became a foundational rubric for assessing quality in medicine.

Over the ensuing decades, with the rise of professional society guidelines and increasing government involvement in the reimbursement of health care, establishing benchmarks and tracking clinical performance has become increasingly important. The passage of the Affordable Care Act subsequently established a formal, legislative mandate for assessing clinical quality tied to reimbursement. Although the context, consequences, and details for reporting have evolved, quality tracking is now firmly entrenched across clinical practice, including gastroenterology. One such mechanism for this is the Merit-Based Incentive Payment System (MIPS), which is a quality payment program (QPP) administered by the Centers for Medicare & Medicaid Services. Today, both government and private payers are assessing measurements and improvements of quality to satisfy the Quintuple Aim of achieving better health outcomes, seeking efficient cost of care, improving patient experience, improving provider experience, and enhancing equity through the reduction health inequalities.

As we transition from a fee-based to a value-based care model, several important developments relevant to the practicing gastroenterologist are likely to occur as the broader landscape of quality reporting will continue shifting. This article will outline a vision of the future in quality measurement for gastroenterology.

Gastroenterologists have relatively few specialty-specific measures on which to report. The widespread use of the adenoma detection rate for screening colonoscopy does represent a success in quality improvement because it is easily calculated, is reproducible, and has been consistently associated with clinical outcomes. But the overall measure set is limited to screening colonoscopy and the management of viral hepatitis, meaning large areas of our practice are not included in this set. Developing new metrics related to broader areas of practice will be necessary to address this current shortcoming and increase the impact of quality programs to clinicians. Indeed, a recent environmental scan performed by the Core Quality Measures Collaborative, a public-private coalition of leaders working to facilitate measure alignment, proposed future areas for development, including gastroesophageal reflux disease, nonalcoholic fatty liver disease, and medication management.

The American Gastroenterological Association, through its defined process of guideline-to-measure development, has responded by creating metrics for the management of acute pancreatitis, Lynch syndrome testing, and eradicating Helicobacter pylori in the context of gastric intestinal metaplasia; additionally, previously defined measures exist for Barrett’s esophagus and inflammatory bowel disease. Therefore, gastroenterologists can expect to report on an expanding collection of measures in the future.

However, recognizing that not all measures may be equally applicable across populations and acknowledging the importance of risk adjustment, incorporating at least an assessment for risk stratification in their future development is vital. Specifically, social risk factors will need to be accounted for during development in ways that might include risk adjustment or stratification by groups. Increasing data demonstrate that clinician performance can vary by population served and that social determinants of health (SDoH) should be incorporated into an assessment of outcomes. Risk stratification may allow clinicians or practices to report outcomes by group without jeopardy of incurring performance-based penalties. However, the ultimate goal should be reducing inequities and closing care gaps rather than inadvertently lowering the bar for clinicians who primarily treat disenfranchised populations. Eventually, any new measures aiming to be included in a QPP require formal validity testing, which can delay their inclusion in such a set. Yet including stratification in their development will provide a more robust and accurate assessment of quality of care delivered according to one’s catchment and help serve to minimize the effects of SDoH.

Another way that quality measurement may account for a more comprehensive assessment of care delivered is by bundling similarly provided services, even those across multiple specialties. Such a future model is the MIPS Value Pathways, currently under development by CMS. While the exact make-up and reporting structure remains to be determined, a group of related metrics – for example, for colonic health – would likely be grouped together. This model might include an evaluation of a practice’s performance in screening colonoscopy, Lynch testing practices, and inflammatory bowel disease management, which could also be relevant to surgeons, pathologists, and oncologists. This paradigm could serve to increase quality alignment across specialties and reinforce a commitment toward improving care delivery and fulfill a value-based mandate.

Within this framework, though, a shared challenge across specialties exists for the capture and reporting of clinical data. The financial and time costs for quality reporting are well documented, therefore any future vision of quality must address means to ease this reporting burden. Accounting for this would be especially impactful to independent as well as small- to moderate-sized practices, which must provide their own resources for collecting and reporting, with the QPP payment adjustments often insufficient to replace lost revenue or expenses. Some administrative relief has been provided by CMS during the current COVID-19 pandemic, but this focused on allowing select clinicians to avoid reporting rather than addressing the fundamental challenges presented by extracting and documenting quality measures. Moving forward, an increasing emphasis will likely be on the use of artificial intelligence (AI), such as natural language processing, combined with discrete code extraction for tracking performance. While AI has the advantage of a more hands-free approach, such a system would itself require monitoring for performance to avoid unintended consequences.

Ultimately, providing high-quality care and improving patient outcomes are universal goals, though demonstrating this aspiration by reporting on quality metrics can be challenging. Quality measurement, though, is now firmly integrated into the fabric of clinical medicine. In the future, more facets of practice will be measured, patient-level factors and cross specialty reporting will increasingly be emphasized, and administrative burdens will be reduced.

Dr. Leiman is assistant professor of medicine at Duke University, Durham, N.C., cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup, and chair of the AGA’s Quality Committee. Dr. Freedman is medical director, SE Territory, Aetna/CVS Health and cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup. Dr. Anjou is a practicing clinical gastroenterologist at Connecticut GI, Torrington, and recent member of the AGA Quality Committee. The authors reported no conflicts related to this article.

Modern efforts to monitor and improve quality in health care can trace their roots to the early 20th century. At that time, hospitals initiated mechanisms to ensure standard practices for privileging clinicians, reporting medical records and clinical data, and establishing supervised diagnostic facilities. Years later, Avedis Donabedian published “Evaluating the Quality of Medical Care,” which outlined how health care should be measured across three areas – structure, process, and outcome – and became a foundational rubric for assessing quality in medicine.

Over the ensuing decades, with the rise of professional society guidelines and increasing government involvement in the reimbursement of health care, establishing benchmarks and tracking clinical performance has become increasingly important. The passage of the Affordable Care Act subsequently established a formal, legislative mandate for assessing clinical quality tied to reimbursement. Although the context, consequences, and details for reporting have evolved, quality tracking is now firmly entrenched across clinical practice, including gastroenterology. One such mechanism for this is the Merit-Based Incentive Payment System (MIPS), which is a quality payment program (QPP) administered by the Centers for Medicare & Medicaid Services. Today, both government and private payers are assessing measurements and improvements of quality to satisfy the Quintuple Aim of achieving better health outcomes, seeking efficient cost of care, improving patient experience, improving provider experience, and enhancing equity through the reduction health inequalities.

As we transition from a fee-based to a value-based care model, several important developments relevant to the practicing gastroenterologist are likely to occur as the broader landscape of quality reporting will continue shifting. This article will outline a vision of the future in quality measurement for gastroenterology.

Gastroenterologists have relatively few specialty-specific measures on which to report. The widespread use of the adenoma detection rate for screening colonoscopy does represent a success in quality improvement because it is easily calculated, is reproducible, and has been consistently associated with clinical outcomes. But the overall measure set is limited to screening colonoscopy and the management of viral hepatitis, meaning large areas of our practice are not included in this set. Developing new metrics related to broader areas of practice will be necessary to address this current shortcoming and increase the impact of quality programs to clinicians. Indeed, a recent environmental scan performed by the Core Quality Measures Collaborative, a public-private coalition of leaders working to facilitate measure alignment, proposed future areas for development, including gastroesophageal reflux disease, nonalcoholic fatty liver disease, and medication management.

The American Gastroenterological Association, through its defined process of guideline-to-measure development, has responded by creating metrics for the management of acute pancreatitis, Lynch syndrome testing, and eradicating Helicobacter pylori in the context of gastric intestinal metaplasia; additionally, previously defined measures exist for Barrett’s esophagus and inflammatory bowel disease. Therefore, gastroenterologists can expect to report on an expanding collection of measures in the future.

However, recognizing that not all measures may be equally applicable across populations and acknowledging the importance of risk adjustment, incorporating at least an assessment for risk stratification in their future development is vital. Specifically, social risk factors will need to be accounted for during development in ways that might include risk adjustment or stratification by groups. Increasing data demonstrate that clinician performance can vary by population served and that social determinants of health (SDoH) should be incorporated into an assessment of outcomes. Risk stratification may allow clinicians or practices to report outcomes by group without jeopardy of incurring performance-based penalties. However, the ultimate goal should be reducing inequities and closing care gaps rather than inadvertently lowering the bar for clinicians who primarily treat disenfranchised populations. Eventually, any new measures aiming to be included in a QPP require formal validity testing, which can delay their inclusion in such a set. Yet including stratification in their development will provide a more robust and accurate assessment of quality of care delivered according to one’s catchment and help serve to minimize the effects of SDoH.

Another way that quality measurement may account for a more comprehensive assessment of care delivered is by bundling similarly provided services, even those across multiple specialties. Such a future model is the MIPS Value Pathways, currently under development by CMS. While the exact make-up and reporting structure remains to be determined, a group of related metrics – for example, for colonic health – would likely be grouped together. This model might include an evaluation of a practice’s performance in screening colonoscopy, Lynch testing practices, and inflammatory bowel disease management, which could also be relevant to surgeons, pathologists, and oncologists. This paradigm could serve to increase quality alignment across specialties and reinforce a commitment toward improving care delivery and fulfill a value-based mandate.

Within this framework, though, a shared challenge across specialties exists for the capture and reporting of clinical data. The financial and time costs for quality reporting are well documented, therefore any future vision of quality must address means to ease this reporting burden. Accounting for this would be especially impactful to independent as well as small- to moderate-sized practices, which must provide their own resources for collecting and reporting, with the QPP payment adjustments often insufficient to replace lost revenue or expenses. Some administrative relief has been provided by CMS during the current COVID-19 pandemic, but this focused on allowing select clinicians to avoid reporting rather than addressing the fundamental challenges presented by extracting and documenting quality measures. Moving forward, an increasing emphasis will likely be on the use of artificial intelligence (AI), such as natural language processing, combined with discrete code extraction for tracking performance. While AI has the advantage of a more hands-free approach, such a system would itself require monitoring for performance to avoid unintended consequences.

Ultimately, providing high-quality care and improving patient outcomes are universal goals, though demonstrating this aspiration by reporting on quality metrics can be challenging. Quality measurement, though, is now firmly integrated into the fabric of clinical medicine. In the future, more facets of practice will be measured, patient-level factors and cross specialty reporting will increasingly be emphasized, and administrative burdens will be reduced.

Dr. Leiman is assistant professor of medicine at Duke University, Durham, N.C., cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup, and chair of the AGA’s Quality Committee. Dr. Freedman is medical director, SE Territory, Aetna/CVS Health and cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup. Dr. Anjou is a practicing clinical gastroenterologist at Connecticut GI, Torrington, and recent member of the AGA Quality Committee. The authors reported no conflicts related to this article.

Modern efforts to monitor and improve quality in health care can trace their roots to the early 20th century. At that time, hospitals initiated mechanisms to ensure standard practices for privileging clinicians, reporting medical records and clinical data, and establishing supervised diagnostic facilities. Years later, Avedis Donabedian published “Evaluating the Quality of Medical Care,” which outlined how health care should be measured across three areas – structure, process, and outcome – and became a foundational rubric for assessing quality in medicine.

Over the ensuing decades, with the rise of professional society guidelines and increasing government involvement in the reimbursement of health care, establishing benchmarks and tracking clinical performance has become increasingly important. The passage of the Affordable Care Act subsequently established a formal, legislative mandate for assessing clinical quality tied to reimbursement. Although the context, consequences, and details for reporting have evolved, quality tracking is now firmly entrenched across clinical practice, including gastroenterology. One such mechanism for this is the Merit-Based Incentive Payment System (MIPS), which is a quality payment program (QPP) administered by the Centers for Medicare & Medicaid Services. Today, both government and private payers are assessing measurements and improvements of quality to satisfy the Quintuple Aim of achieving better health outcomes, seeking efficient cost of care, improving patient experience, improving provider experience, and enhancing equity through the reduction health inequalities.

As we transition from a fee-based to a value-based care model, several important developments relevant to the practicing gastroenterologist are likely to occur as the broader landscape of quality reporting will continue shifting. This article will outline a vision of the future in quality measurement for gastroenterology.

Gastroenterologists have relatively few specialty-specific measures on which to report. The widespread use of the adenoma detection rate for screening colonoscopy does represent a success in quality improvement because it is easily calculated, is reproducible, and has been consistently associated with clinical outcomes. But the overall measure set is limited to screening colonoscopy and the management of viral hepatitis, meaning large areas of our practice are not included in this set. Developing new metrics related to broader areas of practice will be necessary to address this current shortcoming and increase the impact of quality programs to clinicians. Indeed, a recent environmental scan performed by the Core Quality Measures Collaborative, a public-private coalition of leaders working to facilitate measure alignment, proposed future areas for development, including gastroesophageal reflux disease, nonalcoholic fatty liver disease, and medication management.

The American Gastroenterological Association, through its defined process of guideline-to-measure development, has responded by creating metrics for the management of acute pancreatitis, Lynch syndrome testing, and eradicating Helicobacter pylori in the context of gastric intestinal metaplasia; additionally, previously defined measures exist for Barrett’s esophagus and inflammatory bowel disease. Therefore, gastroenterologists can expect to report on an expanding collection of measures in the future.

However, recognizing that not all measures may be equally applicable across populations and acknowledging the importance of risk adjustment, incorporating at least an assessment for risk stratification in their future development is vital. Specifically, social risk factors will need to be accounted for during development in ways that might include risk adjustment or stratification by groups. Increasing data demonstrate that clinician performance can vary by population served and that social determinants of health (SDoH) should be incorporated into an assessment of outcomes. Risk stratification may allow clinicians or practices to report outcomes by group without jeopardy of incurring performance-based penalties. However, the ultimate goal should be reducing inequities and closing care gaps rather than inadvertently lowering the bar for clinicians who primarily treat disenfranchised populations. Eventually, any new measures aiming to be included in a QPP require formal validity testing, which can delay their inclusion in such a set. Yet including stratification in their development will provide a more robust and accurate assessment of quality of care delivered according to one’s catchment and help serve to minimize the effects of SDoH.

Another way that quality measurement may account for a more comprehensive assessment of care delivered is by bundling similarly provided services, even those across multiple specialties. Such a future model is the MIPS Value Pathways, currently under development by CMS. While the exact make-up and reporting structure remains to be determined, a group of related metrics – for example, for colonic health – would likely be grouped together. This model might include an evaluation of a practice’s performance in screening colonoscopy, Lynch testing practices, and inflammatory bowel disease management, which could also be relevant to surgeons, pathologists, and oncologists. This paradigm could serve to increase quality alignment across specialties and reinforce a commitment toward improving care delivery and fulfill a value-based mandate.

Within this framework, though, a shared challenge across specialties exists for the capture and reporting of clinical data. The financial and time costs for quality reporting are well documented, therefore any future vision of quality must address means to ease this reporting burden. Accounting for this would be especially impactful to independent as well as small- to moderate-sized practices, which must provide their own resources for collecting and reporting, with the QPP payment adjustments often insufficient to replace lost revenue or expenses. Some administrative relief has been provided by CMS during the current COVID-19 pandemic, but this focused on allowing select clinicians to avoid reporting rather than addressing the fundamental challenges presented by extracting and documenting quality measures. Moving forward, an increasing emphasis will likely be on the use of artificial intelligence (AI), such as natural language processing, combined with discrete code extraction for tracking performance. While AI has the advantage of a more hands-free approach, such a system would itself require monitoring for performance to avoid unintended consequences.

Ultimately, providing high-quality care and improving patient outcomes are universal goals, though demonstrating this aspiration by reporting on quality metrics can be challenging. Quality measurement, though, is now firmly integrated into the fabric of clinical medicine. In the future, more facets of practice will be measured, patient-level factors and cross specialty reporting will increasingly be emphasized, and administrative burdens will be reduced.

Dr. Leiman is assistant professor of medicine at Duke University, Durham, N.C., cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup, and chair of the AGA’s Quality Committee. Dr. Freedman is medical director, SE Territory, Aetna/CVS Health and cochair of the Core Quality Measure Collaborative Gastroenterology Workgroup. Dr. Anjou is a practicing clinical gastroenterologist at Connecticut GI, Torrington, and recent member of the AGA Quality Committee. The authors reported no conflicts related to this article.

The rapid and unprecedented expansion of virtual care in response to COVID-19 is likely to leave a permanent mark on how health care is delivered. While this expansion has been critical in the near term in caring for our patients while minimizing risk of exposure during the pandemic, it is vital to be forward thinking in considering the ongoing value of virtual care in optimizing routine patient care and in reaching our high-need patients in rural and other underserved areas. We are likely to hear more in the coming months regarding the short- and long-term impacts of virtual care expansion as we transition away from COVID and begin to consider how to maximize use of virtual care in our routine practice. Many questions remain, including defining the optimal balance between virtual and in-person care, assessing whether virtual care is a substitute for in-person care or simply additive, and understanding the impacts of virtual care on outcomes. On the latter questions, a recent study from Kaiser Permanente Northern California found that primary care visits conducted virtually resulted in modestly higher rates of follow-up outpatient office visits than initial in-person visits, but no significant difference in 7-day ED visits or hospitalizations. Whether these results are generalizable to GI patient populations is unclear.

Highlights from this month’s issue of GIHN include a study evaluating the impact of a “virtual” liver transplant center on access to liver transplant listing among patients in rural areas, another suggesting lower serologic response to COVID-19 vaccines among patients with IBD, a new AGA Clinical Practice Update: Commentary offering tips regarding surveillance after endoscopic submucosal dissection for dysplasia and early-stage GI cancer, and results from a phase 3 clinical trial demonstrating the efficacy of upadacitinib for treatment of moderate to severe ulcerative colitis.

And while the winter weather here in Michigan may suggest otherwise, DDW 2022 is just around the corner – registration opens on Jan. 19, and we look forward to the GI community coming together, whether in person in sunny San Diego or virtually at home or office, for this hybrid conference.

Megan A. Adams, MD, JD, MSc
Editor in Chief

The rapid and unprecedented expansion of virtual care in response to COVID-19 is likely to leave a permanent mark on how health care is delivered. While this expansion has been critical in the near term in caring for our patients while minimizing risk of exposure during the pandemic, it is vital to be forward thinking in considering the ongoing value of virtual care in optimizing routine patient care and in reaching our high-need patients in rural and other underserved areas. We are likely to hear more in the coming months regarding the short- and long-term impacts of virtual care expansion as we transition away from COVID and begin to consider how to maximize use of virtual care in our routine practice. Many questions remain, including defining the optimal balance between virtual and in-person care, assessing whether virtual care is a substitute for in-person care or simply additive, and understanding the impacts of virtual care on outcomes. On the latter questions, a recent study from Kaiser Permanente Northern California found that primary care visits conducted virtually resulted in modestly higher rates of follow-up outpatient office visits than initial in-person visits, but no significant difference in 7-day ED visits or hospitalizations. Whether these results are generalizable to GI patient populations is unclear.

Highlights from this month’s issue of GIHN include a study evaluating the impact of a “virtual” liver transplant center on access to liver transplant listing among patients in rural areas, another suggesting lower serologic response to COVID-19 vaccines among patients with IBD, a new AGA Clinical Practice Update: Commentary offering tips regarding surveillance after endoscopic submucosal dissection for dysplasia and early-stage GI cancer, and results from a phase 3 clinical trial demonstrating the efficacy of upadacitinib for treatment of moderate to severe ulcerative colitis.

And while the winter weather here in Michigan may suggest otherwise, DDW 2022 is just around the corner – registration opens on Jan. 19, and we look forward to the GI community coming together, whether in person in sunny San Diego or virtually at home or office, for this hybrid conference.

Megan A. Adams, MD, JD, MSc
Editor in Chief

The rapid and unprecedented expansion of virtual care in response to COVID-19 is likely to leave a permanent mark on how health care is delivered. While this expansion has been critical in the near term in caring for our patients while minimizing risk of exposure during the pandemic, it is vital to be forward thinking in considering the ongoing value of virtual care in optimizing routine patient care and in reaching our high-need patients in rural and other underserved areas. We are likely to hear more in the coming months regarding the short- and long-term impacts of virtual care expansion as we transition away from COVID and begin to consider how to maximize use of virtual care in our routine practice. Many questions remain, including defining the optimal balance between virtual and in-person care, assessing whether virtual care is a substitute for in-person care or simply additive, and understanding the impacts of virtual care on outcomes. On the latter questions, a recent study from Kaiser Permanente Northern California found that primary care visits conducted virtually resulted in modestly higher rates of follow-up outpatient office visits than initial in-person visits, but no significant difference in 7-day ED visits or hospitalizations. Whether these results are generalizable to GI patient populations is unclear.

Highlights from this month’s issue of GIHN include a study evaluating the impact of a “virtual” liver transplant center on access to liver transplant listing among patients in rural areas, another suggesting lower serologic response to COVID-19 vaccines among patients with IBD, a new AGA Clinical Practice Update: Commentary offering tips regarding surveillance after endoscopic submucosal dissection for dysplasia and early-stage GI cancer, and results from a phase 3 clinical trial demonstrating the efficacy of upadacitinib for treatment of moderate to severe ulcerative colitis.

And while the winter weather here in Michigan may suggest otherwise, DDW 2022 is just around the corner – registration opens on Jan. 19, and we look forward to the GI community coming together, whether in person in sunny San Diego or virtually at home or office, for this hybrid conference.

Megan A. Adams, MD, JD, MSc
Editor in Chief

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

Dear colleagues and friends,

After an excellent debate on the future of telemedicine in GI in our most recent Perspectives column, we continue to explore changes in the way we traditionally provide care. In this issue, we discuss the GI hospitalist service, a relatively new but growing model of providing inpatient care. Is this the new ideal, allowing for more efficient care? Or are traditional or alternative models more appropriate? As with most things, the answer often lies somewhere in the middle, driven by local needs and infrastructure. Dr. Tau and Dr. Mehendiratta explore the pros and cons of these different approaches to providing inpatient GI care. I look forward to hearing your thoughts and experiences on the AGA Community forum and by email ([email protected]).

Gyanprakash A. Ketwaroo, MD, MSc, is an assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

The dedicated GI hospitalist: Taking ownership not ‘call’

By J. Andy Tau, MD

In my experience, a GI hospitalist provides mutual benefit to patients, employers, and consulting physicians. The patient benefits from more expedient consultations and expert endoscopic therapy, which translates to shorter hospitalizations and improved outcomes. The employer enjoys financial benefits as busy outpatient providers can stay busy without interruption. Consulting physicians enjoy having to only call a single phone number for trusted help from a familiar physician who does not rotate off service. Personally, the position provides the volume to develop valuable therapeutic endoscopy skills and techniques. With one stable physician at the helm, a sense of ownership can develop, rather than a sense of survival until “call” is over.

As a full-time GI hospitalist for a large single-specialty group, I provide inpatient GI and hepatology consultation from 7 a.m. to 5 p.m., Monday-Friday. I do not rotate off service. I cover three hospitals with a total of 1,000 beds with two advanced practice providers and one part-time physician. Except for endoscopic ultrasound, I perform all other endoscopic procedures. The census is usually 25-35 with an average of 10-15 new consults per day.

The most important benefit of a dedicated GI hospitalist is providing expedited consultation and expert endoscopy for patients. I can offer emergent (<6 hour) endoscopy for any patient. An esophageal food impaction is usually resolved within an hour of arrival to the ED during the day. I can help a surgeon intraoperatively on very short notice. As for acute GI bleeding cases, I oversee resuscitative efforts, while the endoscopy team prepares my preferred endoscopic equipment, eliminating surprises and delays before endoscopy. I have developed an expertise in hemostasis and managing esophageal perforations, along with a risk tolerance that cannot be matured in any setting other than daily emergency.

I have enacted evidence-based protocols for GI bleeding, iron-deficiency anemia, colonic pseudo-obstruction, pancreatitis, and liver decompensation, which internists have adopted over time, reducing phone calls and delays in prep or resuscitation.

While the day is unstructured and filled with interruptions, it is also very flexible. As opposed to the set time intervals of an outpatient clinic visit, I can spend an hour in a palliative care meeting or revisit high-risk patients multiple times a day to detect pending deterioration. Combined endoscopic and surgical cases are logistically easy to schedule given my flexibility. For example, patients with choledocholithiasis often can have a combined cholecystectomy and supine endoscopic retrograde cholangiopancreatography (ERCP) in the OR, shaving a day off admission.

My employer benefits financially as the outpatient doctors can stay busy without interruption from the hospital. With secure group messaging, we are able to make joint decisions and arrange close follow up. The relative value units earned from the hospital are high. Combined with proceeds from the professional service agreement with the hospital, they are more than enough to cover my compensation.

Any physician in need of a GI consult needs only to call one number for help. I make it as easy as possible to obtain a consult and never push back, as banal as any consult may seem. I stake my reputation on providing a service that is able, affable, and available. By teaching a consistent message to consulting physicians, I have now effected best evidence-based practices for GI conditions even without engaging me. The most notable examples include antibiotics for variceal bleeding, fluid resuscitation and early feeding for acute pancreatitis, risk stratification for choledocholithiasis, and last but not least, abandoning the inpatient fecal occult blood test.

I am on a first-name basis with every nurse in the hospital now. In exchange for my availability and cell phone number, they place orders for me and protect me from avoidable nuisances.

Many physician groups cover the inpatient service by rotating a week at a time. There can be at times a reluctance to take ownership over a difficult patient and instead a sense of “survival of the call”. However, in my job, “the buck stops with me” even if it is in the form of readmission. For example, I have to take some ownership of indigent patients who cannot easily follow up. Who will remove the stent I placed? How will they pay for Helicobacter pylori eradication or biologic therapy? Another example is diverticular bleeding. While 80% stop on their own, I take extraordinary efforts to endoscopically find and halt the bleeding in order to reduce the recurrence rate. I must find durable solutions because these high-risk patients are my responsibility again when they bounce back to me via the ED.

By way of volume alone, this position has allowed me to develop many therapeutic skills outside of a standard 3-year GI fellowship. While I did only 200 ERCPs in fellowship, I have become proficient in ERCP with around 400 cases per year (mostly native papilla) and have grown comfortable with the needle knife. I have learned endoscopic suturing, luminal stenting, and endoscopic vacuum-assisted therapy for perforation closure independently. Out of necessity, I developed a novel technique in optimizing the use of hemostatic powder by using a bone-wax plug. As endoscopy chief, I can purchase a wide variety of endoscopy equipment, compare brands, and understand the nuances of each.

In conclusion, the dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist. While it can be challenging and hectic, with the right mentality towards ownership of the service, it is also an incredibly rewarding position.

Dr. Tau practices with Austin Gastroenterology in Austin, Tex. He disclosed relationships with Cook Medical and Conmed.

Inpatient-only GI hospitalist: Not so fast

By Vaibhav Mehendiratta, MD

Over the past 2 decades, the medical hospitalist system has assumed care of hospitalized patients with the promise of reduced length of stay (LOS) and improved outcomes. Although data on LOS is promising, there have been conflicting results in terms of total medical costs and resource utilization. Inpatient care for patients with complex medical histories often requires regular communication with other subspecialties and outpatient providers to achieve better patient-centered outcomes.

Courtesy Connecticut GI, PC

Providing inpatient gastrointestinal care is complicated. Traditional models rely on physicians trying to balance outpatient obligations with inpatient rounding and procedures, which can result in delayed endoscopy and an inability to participate fully in multidisciplinary rounds and family meetings. The complexity of hospitalized patients often requires a multidisciplinary approach with coordination of care that is hard to accomplish in between seeing outpatients. GI groups, both private practice and academics, need to adopt a strategy for inpatient care that is tailored to the hospital system in which they operate.

As one of the largest private practice groups in New England, our experience can provide a framework for others to follow. We provide inpatient GI care at eight hospitals across northern Connecticut. Our inpatient service at the largest tertiary care hospital is composed of one general gastroenterologist, one advanced endoscopist, one transplant hepatologist, two advanced practitioners, and two fellows in training. Each practitioner provides coverage on a rotating basis, typically 1 week at a time every 4-8 weeks. This model also offers flexibility, such that we can typically accommodate urgent outpatient endoscopy for patients who may otherwise require inpatient care. Coverage at the other seven hospitals is tailored to local needs and ranges from half-day to whole-day coverage by general gastroenterologists and advanced practitioners. We believe that our model is financially viable and, based on our experience, inpatient relative value units generated are quite similar to a typical day in outpatient GI practice.

Inpatient GI care accounts for a substantial portion of overall inpatient care in the United States. Endoscopy delays have been the focus of many research articles looking at inpatient GI care. The delays are caused by many factors, including endoscopy unit/staff availability, anesthesia availability, and patient factors. While having a dedicated inpatient GI Hospitalist offers the potential to streamline access for hospital consultations and endoscopy, an exclusive inpatient GI hospitalist may be less familiar with a patient’s chronic GI illness and have different (and perhaps, conflicting) priorities regarding a patient’s care. Having incomplete access to outpatient records or less familiarity with the intricacies of outpatient care could also lead to duplication of work and increase the number of inpatient procedures that may have otherwise been deferred to the outpatient setting.

Additionally, with physician burnout on the rise and particularly in the inpatient setting, one must question the sustainability of an exclusively inpatient GI practice. That is, the hours and demands of inpatient care typically do not allow the quality of life that outpatient care provides. Our model provides time for dedicated inpatient care, while allowing each practitioner ample opportunity to build a robust outpatient practice.

Some health care organizations are adopting an extensivist model to provide comprehensive care to patients with multiple medical problems. Extensivists are outpatient primary care providers who take the time to coordinate with inpatient hospitalists to provide comprehensive care to their patients. Constant contact with outpatient providers during admission is expected to improve patient satisfaction, reduce hospital readmissions, and decrease inpatient resource utilization.

In conclusion, our experience highlights sustained benefits, and distinct advantages, of providing inpatient GI care without a GI hospitalist model. The pendulum in inpatient care keeps swinging and with progress arise new challenges and questions. Close collaboration between gastroenterologists and health systems to develop a program that fits local needs and allows optimal resource allocation will ensure delivery of high-quality inpatient GI care.

Dr. Mehendiratta is a gastroenterologist with Connecticut GI PC, Hartford, and assistant clinical professor in the department of medicine at the University of Connecticut, Farmington. He has no relevant conflicts of interest to disclose.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion: 

Vivy Tran, MD, wrote in “Definitive diverticular hemorrhage: Diagnosis and management”:

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults. Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage. The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage in a single diverticulum, which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot. Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques.

Would love to hear how diverticular bleeds are managed at your institution.

See how AGA members responded and join the discussion.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion: 

Vivy Tran, MD, wrote in “Definitive diverticular hemorrhage: Diagnosis and management”:

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults. Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage. The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage in a single diverticulum, which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot. Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques.

Would love to hear how diverticular bleeds are managed at your institution.

See how AGA members responded and join the discussion.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion: 

Vivy Tran, MD, wrote in “Definitive diverticular hemorrhage: Diagnosis and management”:

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults. Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage. The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage in a single diverticulum, which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot. Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques.

Would love to hear how diverticular bleeds are managed at your institution.

See how AGA members responded and join the discussion.

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.