Heidi Splete

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

A plant-based fusion protein is safe and effective for inducing favorable immune modulation in patients with mild to moderate ulcerative colitis with no immune suppression–side effects reported.

OPRX-106, an orally administered BY2 plant cell–expressing recombinant TNF fusion protein, has demonstrated effectiveness as an anti–TNF-alpha therapy, according to Einat Almon, PhD, of Protalix Biotherapeutics, and colleagues.

“Oral immune therapy is based on the concept of oral administration of nonabsorbable compounds which target the gut immune system to redirect the systemic immune system toward an anti-inflammatory direction, without immunosuppression,” the researchers said.

A phase 1 study of OPRX-106 in healthy human volunteers showed safety and immune modulatory effects at doses of 2, 8, or 16 mg/day.

In this phase 2a clinical trial published in the Journal of Clinical Gastroenterology, the researchers enrolled 24 patients with ulcerative colitis (11 male and 13 female) aged 23-73 years, with an average age of 42.6 years. Patients received either 2 mg or 8 mg of OPRX-106 at least once daily for 8 weeks. All patients were monitored for 6 hours after receiving medication on day 1 and week 8 for pharmacokinetic sampling, and a lower endoscopy was performed at week 8.

After 8 weeks, 67% of the patients demonstrated clinical response and 28% showed clinical remission.

Clinical response and clinical remission were defined by a specific set of criteria including improvement in the Mayo score. Clinical response was a “decrease in the Mayo score of at least 3 points, decrease in the subscore for rectal bleeding of at least 1 point, [and] a rectal bleeding subscore of 0 or 1.” Clinical remission at week 8 was defined as “clinically symptom-free, Mayo score of ≤2 with no individual subscore exceeding 1 point after treatment, histopathological improvement in Geboes histologic grading from baseline to week 8, improvement in high sensitivity C-reactive protein levels from baseline to week 8, improvement in fecal calprotectin levels from baseline to week 8, and changes in systemic immune modulation parameters from baseline to week 8.”

In addition, 89% of the patients experienced some degree of improvement in their Mayo scores, 61% had mucosal improvement, and 33% achieved mucosal healing.

No side effects associated with general immune suppression were reported. No patients discontinued the study because of adverse events, the researchers said. However, overall, 40 adverse events were reported in 15 patients; 95% of these were mild to moderate and 40% were reported as treatment related. No differences appeared in adverse events related to the two doses.

Evidence of a systemic anti-inflammatory effect was seen with a decrease in serum levels of the pro-inflammatory cytokines interleukin-6 and interferon-gamma that correlated with the clinical response, the researchers noted. Similarly, an increase in the CD3+CD4+CD25+Foxp3+ subset of suppressor lymphocytes correlated with clinical response.

The study findings were limited by the small sample size, open-label design, and lack of control subjects. However, by targeting the gut immune system, the drug “may provide an answer to the long-term immune suppression encountered in patients with chronic disorders who use these agents for prolonged periods of time, in addition to loss of response due to neutralizing antibodies,” they concluded.
 

Findings provide foundation for further research

“Conducting a study of a novel treatment for ulcerative colitis is valuable and timely because the available options are limited,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview. “The currently available TNF antagonists are administered intravenously or subcutaneously and bear the risk of infectious complications, so the development of an agent that can be administered orally with fewer side effects is of importance.”

Although the data are preliminary, Dr. Sakuraba emphasized that the take-home message for clinicians is that “the present open-label study consisting of a small number of subjects demonstrated that OPRX-106 was effective and safe in active ulcerative colitis, so further investigation is warranted. Larger-powered, randomized, placebo-controlled studies are needed to confirm these findings.”

The study was supported by Protalix Biotherapeutics; Dr. Almon and several coauthors are employed by Protalix Biotherapeutics. Dr. Sakuraba had no financial conflicts to disclose.

A plant-based fusion protein is safe and effective for inducing favorable immune modulation in patients with mild to moderate ulcerative colitis with no immune suppression–side effects reported.

OPRX-106, an orally administered BY2 plant cell–expressing recombinant TNF fusion protein, has demonstrated effectiveness as an anti–TNF-alpha therapy, according to Einat Almon, PhD, of Protalix Biotherapeutics, and colleagues.

“Oral immune therapy is based on the concept of oral administration of nonabsorbable compounds which target the gut immune system to redirect the systemic immune system toward an anti-inflammatory direction, without immunosuppression,” the researchers said.

A phase 1 study of OPRX-106 in healthy human volunteers showed safety and immune modulatory effects at doses of 2, 8, or 16 mg/day.

In this phase 2a clinical trial published in the Journal of Clinical Gastroenterology, the researchers enrolled 24 patients with ulcerative colitis (11 male and 13 female) aged 23-73 years, with an average age of 42.6 years. Patients received either 2 mg or 8 mg of OPRX-106 at least once daily for 8 weeks. All patients were monitored for 6 hours after receiving medication on day 1 and week 8 for pharmacokinetic sampling, and a lower endoscopy was performed at week 8.

After 8 weeks, 67% of the patients demonstrated clinical response and 28% showed clinical remission.

Clinical response and clinical remission were defined by a specific set of criteria including improvement in the Mayo score. Clinical response was a “decrease in the Mayo score of at least 3 points, decrease in the subscore for rectal bleeding of at least 1 point, [and] a rectal bleeding subscore of 0 or 1.” Clinical remission at week 8 was defined as “clinically symptom-free, Mayo score of ≤2 with no individual subscore exceeding 1 point after treatment, histopathological improvement in Geboes histologic grading from baseline to week 8, improvement in high sensitivity C-reactive protein levels from baseline to week 8, improvement in fecal calprotectin levels from baseline to week 8, and changes in systemic immune modulation parameters from baseline to week 8.”

In addition, 89% of the patients experienced some degree of improvement in their Mayo scores, 61% had mucosal improvement, and 33% achieved mucosal healing.

No side effects associated with general immune suppression were reported. No patients discontinued the study because of adverse events, the researchers said. However, overall, 40 adverse events were reported in 15 patients; 95% of these were mild to moderate and 40% were reported as treatment related. No differences appeared in adverse events related to the two doses.

Evidence of a systemic anti-inflammatory effect was seen with a decrease in serum levels of the pro-inflammatory cytokines interleukin-6 and interferon-gamma that correlated with the clinical response, the researchers noted. Similarly, an increase in the CD3+CD4+CD25+Foxp3+ subset of suppressor lymphocytes correlated with clinical response.

The study findings were limited by the small sample size, open-label design, and lack of control subjects. However, by targeting the gut immune system, the drug “may provide an answer to the long-term immune suppression encountered in patients with chronic disorders who use these agents for prolonged periods of time, in addition to loss of response due to neutralizing antibodies,” they concluded.
 

Findings provide foundation for further research

“Conducting a study of a novel treatment for ulcerative colitis is valuable and timely because the available options are limited,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview. “The currently available TNF antagonists are administered intravenously or subcutaneously and bear the risk of infectious complications, so the development of an agent that can be administered orally with fewer side effects is of importance.”

Although the data are preliminary, Dr. Sakuraba emphasized that the take-home message for clinicians is that “the present open-label study consisting of a small number of subjects demonstrated that OPRX-106 was effective and safe in active ulcerative colitis, so further investigation is warranted. Larger-powered, randomized, placebo-controlled studies are needed to confirm these findings.”

The study was supported by Protalix Biotherapeutics; Dr. Almon and several coauthors are employed by Protalix Biotherapeutics. Dr. Sakuraba had no financial conflicts to disclose.

A plant-based fusion protein is safe and effective for inducing favorable immune modulation in patients with mild to moderate ulcerative colitis with no immune suppression–side effects reported.

OPRX-106, an orally administered BY2 plant cell–expressing recombinant TNF fusion protein, has demonstrated effectiveness as an anti–TNF-alpha therapy, according to Einat Almon, PhD, of Protalix Biotherapeutics, and colleagues.

“Oral immune therapy is based on the concept of oral administration of nonabsorbable compounds which target the gut immune system to redirect the systemic immune system toward an anti-inflammatory direction, without immunosuppression,” the researchers said.

A phase 1 study of OPRX-106 in healthy human volunteers showed safety and immune modulatory effects at doses of 2, 8, or 16 mg/day.

In this phase 2a clinical trial published in the Journal of Clinical Gastroenterology, the researchers enrolled 24 patients with ulcerative colitis (11 male and 13 female) aged 23-73 years, with an average age of 42.6 years. Patients received either 2 mg or 8 mg of OPRX-106 at least once daily for 8 weeks. All patients were monitored for 6 hours after receiving medication on day 1 and week 8 for pharmacokinetic sampling, and a lower endoscopy was performed at week 8.

After 8 weeks, 67% of the patients demonstrated clinical response and 28% showed clinical remission.

Clinical response and clinical remission were defined by a specific set of criteria including improvement in the Mayo score. Clinical response was a “decrease in the Mayo score of at least 3 points, decrease in the subscore for rectal bleeding of at least 1 point, [and] a rectal bleeding subscore of 0 or 1.” Clinical remission at week 8 was defined as “clinically symptom-free, Mayo score of ≤2 with no individual subscore exceeding 1 point after treatment, histopathological improvement in Geboes histologic grading from baseline to week 8, improvement in high sensitivity C-reactive protein levels from baseline to week 8, improvement in fecal calprotectin levels from baseline to week 8, and changes in systemic immune modulation parameters from baseline to week 8.”

In addition, 89% of the patients experienced some degree of improvement in their Mayo scores, 61% had mucosal improvement, and 33% achieved mucosal healing.

No side effects associated with general immune suppression were reported. No patients discontinued the study because of adverse events, the researchers said. However, overall, 40 adverse events were reported in 15 patients; 95% of these were mild to moderate and 40% were reported as treatment related. No differences appeared in adverse events related to the two doses.

Evidence of a systemic anti-inflammatory effect was seen with a decrease in serum levels of the pro-inflammatory cytokines interleukin-6 and interferon-gamma that correlated with the clinical response, the researchers noted. Similarly, an increase in the CD3+CD4+CD25+Foxp3+ subset of suppressor lymphocytes correlated with clinical response.

The study findings were limited by the small sample size, open-label design, and lack of control subjects. However, by targeting the gut immune system, the drug “may provide an answer to the long-term immune suppression encountered in patients with chronic disorders who use these agents for prolonged periods of time, in addition to loss of response due to neutralizing antibodies,” they concluded.
 

Findings provide foundation for further research

“Conducting a study of a novel treatment for ulcerative colitis is valuable and timely because the available options are limited,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview. “The currently available TNF antagonists are administered intravenously or subcutaneously and bear the risk of infectious complications, so the development of an agent that can be administered orally with fewer side effects is of importance.”

Although the data are preliminary, Dr. Sakuraba emphasized that the take-home message for clinicians is that “the present open-label study consisting of a small number of subjects demonstrated that OPRX-106 was effective and safe in active ulcerative colitis, so further investigation is warranted. Larger-powered, randomized, placebo-controlled studies are needed to confirm these findings.”

The study was supported by Protalix Biotherapeutics; Dr. Almon and several coauthors are employed by Protalix Biotherapeutics. Dr. Sakuraba had no financial conflicts to disclose.

Although the COVID-19 pandemic put telehealth on fast forward, more than one third of patients in the United States engaged with telehealth services before February 2020, according to Ameet Doshi, MD, and Chrisanne Timpe, MD, of HealthPartners in Bloomington, Minn.

Broadly speaking, telehealth is “using virtual tools to evaluate, manage, and care for our patients, regardless of where they are located,” Dr. Doshi said during a May 6 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The entirety of telehealth includes remote ways to meet almost any patient demand, he said. Some common health terms are used interchangeably, but some use telehealth as a broad term for electronic health care services, while telemedicine may refer specifically to remote patient care, he said.

Telemedicine allows flexibility of delivering patient care in inpatient, outpatient, or at-home settings, said Dr. Doshi. To illustrate the current application of telemedicine, he used an example of a 25-bed critical access hospital serving a growing regional population in which outpatient volume is expanding and ambulatory care services are being added. In this example, inpatient volume is growing, but not enough to support an inpatient consult service, but telehealth access to specialists such as cardiology would be useful in this case, he said.

Hospitalist telehealth means “being able to provide services to changing patient populations regardless of location; we can bring services to where patients are,” said Dr. Doshi.

Benefits of telehealth to patients include less travel and easier access to care, benefits to clinicians include expanding services at lower financial costs, he said.
 

COVID-19 challenges and opportunities

The COVID-19 pandemic presented both challenges and opportunities for telehealth, Dr. Doshi said. One opportunity was the sudden broad acceptance of virtual care out of necessity and concern for patient and staff safety, and to preserve the use of personal protective equipment, he said. In addition, a loosening of regulatory and financial pressures allowed more institutions to expand and initiate telehealth services.

Challenges included technological limitations and, in some cases, the need to develop a telehealth infrastructure from scratch, Dr. Doshi explained. Concerns also remain regarding how telehealth will evolve in the post-pandemic future, he said.

In the meantime, Medicare data show the impact of the pandemic on telehealth services, said Dr. Doshi. A telehealth waiver issued in March 2020 led to an increase in virtual encounters, and Medicare data show approximately 25 million virtual Medicare encounters between March 2020 and October 2020, representing a 3,000% increase from the same period in 2019, he said.

“Telehealth is here to stay, so the questions are how to craft a hospitalist telehealth program and provide essential patient care,” he said.

Dr. Timpe shared some examples of the evolution of telehealth care during the pandemic, including a case of an asymptomatic but frail patient with diabetes, dementia, and coronary artery disease undergoing outpatient care for a foot infection. The patient presented to an emergency department but refused to be hospitalized because of family concerns about patient isolation (no visitors were allowed at the time) and the concerns about COVID-19 infection.

The need to help treat acutely ill patients such as this patient while avoiding hospital admission during and after the pandemic continues to lead to the development of telehealth programs, Dr. Timpe said. She shared details of the Hospital@Home program developed by her organization, Health Partners. The program is designed to treat acutely ill people in the home, if possible, and avoid the need for hospital admission. Patients receive daily medical management from a hospitalist and care from staff, including registered nurses and community paramedics. Services include provision of IV medications and fluids, but the staff also conduct labs and imaging services, Dr. Timpe said.

Conditions that the program has managed at patients’ homes include pneumonia, COPD, asthma, bronchitis, flu, COVID-19, congestive heart failure, cellulitis, and urinary tract infections, said Dr. Timpe.

“We do not accept people into the program who have treatment needs that can only be met in a hospital,” such as the need for blood products, vasopressor support, telemetry, or positive pressure support, she noted.

Between November 2019 and February 15, 2021, the Hospital@Home program has provided services to 132 patients for a total of 287 visits. The program has averted 50 emergency department visits and 40 hospitalizations, and shorted hospital stays in 57 cases, she noted.

Hospitalists are suited for telehealth for several reasons, including the ability to triage acutely ill patients, familiarity with resource utilization, and expertise in management of complex medical care, said Dr. Timpe.
 

Looking ahead

Dr. Doshi emphasized several ongoing issues regarding the future of telemedicine, primarily the need for standardized regulation and reimbursement; reduction of health equity disparity and attention to technological barriers (including access and technology literacy); and identification of the next frontiers in telehealth.

Research on the impact and effectiveness of telehealth is limited, but growing, and next frontiers might include making patients more active participants in telehealth via patient-operated kits, or the option of an open telemedicine marketplace, in which patients can select providers from across the country, he said. No matter where telehealth leads in the future, “we need to make sure we have a positive patient outcome,” he concluded.

Dr. Doshi and Dr. Timpe had no financial conflicts to disclose.

Although the COVID-19 pandemic put telehealth on fast forward, more than one third of patients in the United States engaged with telehealth services before February 2020, according to Ameet Doshi, MD, and Chrisanne Timpe, MD, of HealthPartners in Bloomington, Minn.

Broadly speaking, telehealth is “using virtual tools to evaluate, manage, and care for our patients, regardless of where they are located,” Dr. Doshi said during a May 6 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The entirety of telehealth includes remote ways to meet almost any patient demand, he said. Some common health terms are used interchangeably, but some use telehealth as a broad term for electronic health care services, while telemedicine may refer specifically to remote patient care, he said.

Telemedicine allows flexibility of delivering patient care in inpatient, outpatient, or at-home settings, said Dr. Doshi. To illustrate the current application of telemedicine, he used an example of a 25-bed critical access hospital serving a growing regional population in which outpatient volume is expanding and ambulatory care services are being added. In this example, inpatient volume is growing, but not enough to support an inpatient consult service, but telehealth access to specialists such as cardiology would be useful in this case, he said.

Hospitalist telehealth means “being able to provide services to changing patient populations regardless of location; we can bring services to where patients are,” said Dr. Doshi.

Benefits of telehealth to patients include less travel and easier access to care, benefits to clinicians include expanding services at lower financial costs, he said.
 

COVID-19 challenges and opportunities

The COVID-19 pandemic presented both challenges and opportunities for telehealth, Dr. Doshi said. One opportunity was the sudden broad acceptance of virtual care out of necessity and concern for patient and staff safety, and to preserve the use of personal protective equipment, he said. In addition, a loosening of regulatory and financial pressures allowed more institutions to expand and initiate telehealth services.

Challenges included technological limitations and, in some cases, the need to develop a telehealth infrastructure from scratch, Dr. Doshi explained. Concerns also remain regarding how telehealth will evolve in the post-pandemic future, he said.

In the meantime, Medicare data show the impact of the pandemic on telehealth services, said Dr. Doshi. A telehealth waiver issued in March 2020 led to an increase in virtual encounters, and Medicare data show approximately 25 million virtual Medicare encounters between March 2020 and October 2020, representing a 3,000% increase from the same period in 2019, he said.

“Telehealth is here to stay, so the questions are how to craft a hospitalist telehealth program and provide essential patient care,” he said.

Dr. Timpe shared some examples of the evolution of telehealth care during the pandemic, including a case of an asymptomatic but frail patient with diabetes, dementia, and coronary artery disease undergoing outpatient care for a foot infection. The patient presented to an emergency department but refused to be hospitalized because of family concerns about patient isolation (no visitors were allowed at the time) and the concerns about COVID-19 infection.

The need to help treat acutely ill patients such as this patient while avoiding hospital admission during and after the pandemic continues to lead to the development of telehealth programs, Dr. Timpe said. She shared details of the Hospital@Home program developed by her organization, Health Partners. The program is designed to treat acutely ill people in the home, if possible, and avoid the need for hospital admission. Patients receive daily medical management from a hospitalist and care from staff, including registered nurses and community paramedics. Services include provision of IV medications and fluids, but the staff also conduct labs and imaging services, Dr. Timpe said.

Conditions that the program has managed at patients’ homes include pneumonia, COPD, asthma, bronchitis, flu, COVID-19, congestive heart failure, cellulitis, and urinary tract infections, said Dr. Timpe.

“We do not accept people into the program who have treatment needs that can only be met in a hospital,” such as the need for blood products, vasopressor support, telemetry, or positive pressure support, she noted.

Between November 2019 and February 15, 2021, the Hospital@Home program has provided services to 132 patients for a total of 287 visits. The program has averted 50 emergency department visits and 40 hospitalizations, and shorted hospital stays in 57 cases, she noted.

Hospitalists are suited for telehealth for several reasons, including the ability to triage acutely ill patients, familiarity with resource utilization, and expertise in management of complex medical care, said Dr. Timpe.
 

Looking ahead

Dr. Doshi emphasized several ongoing issues regarding the future of telemedicine, primarily the need for standardized regulation and reimbursement; reduction of health equity disparity and attention to technological barriers (including access and technology literacy); and identification of the next frontiers in telehealth.

Research on the impact and effectiveness of telehealth is limited, but growing, and next frontiers might include making patients more active participants in telehealth via patient-operated kits, or the option of an open telemedicine marketplace, in which patients can select providers from across the country, he said. No matter where telehealth leads in the future, “we need to make sure we have a positive patient outcome,” he concluded.

Dr. Doshi and Dr. Timpe had no financial conflicts to disclose.

Although the COVID-19 pandemic put telehealth on fast forward, more than one third of patients in the United States engaged with telehealth services before February 2020, according to Ameet Doshi, MD, and Chrisanne Timpe, MD, of HealthPartners in Bloomington, Minn.

Broadly speaking, telehealth is “using virtual tools to evaluate, manage, and care for our patients, regardless of where they are located,” Dr. Doshi said during a May 6 session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The entirety of telehealth includes remote ways to meet almost any patient demand, he said. Some common health terms are used interchangeably, but some use telehealth as a broad term for electronic health care services, while telemedicine may refer specifically to remote patient care, he said.

Telemedicine allows flexibility of delivering patient care in inpatient, outpatient, or at-home settings, said Dr. Doshi. To illustrate the current application of telemedicine, he used an example of a 25-bed critical access hospital serving a growing regional population in which outpatient volume is expanding and ambulatory care services are being added. In this example, inpatient volume is growing, but not enough to support an inpatient consult service, but telehealth access to specialists such as cardiology would be useful in this case, he said.

Hospitalist telehealth means “being able to provide services to changing patient populations regardless of location; we can bring services to where patients are,” said Dr. Doshi.

Benefits of telehealth to patients include less travel and easier access to care, benefits to clinicians include expanding services at lower financial costs, he said.
 

COVID-19 challenges and opportunities

The COVID-19 pandemic presented both challenges and opportunities for telehealth, Dr. Doshi said. One opportunity was the sudden broad acceptance of virtual care out of necessity and concern for patient and staff safety, and to preserve the use of personal protective equipment, he said. In addition, a loosening of regulatory and financial pressures allowed more institutions to expand and initiate telehealth services.

Challenges included technological limitations and, in some cases, the need to develop a telehealth infrastructure from scratch, Dr. Doshi explained. Concerns also remain regarding how telehealth will evolve in the post-pandemic future, he said.

In the meantime, Medicare data show the impact of the pandemic on telehealth services, said Dr. Doshi. A telehealth waiver issued in March 2020 led to an increase in virtual encounters, and Medicare data show approximately 25 million virtual Medicare encounters between March 2020 and October 2020, representing a 3,000% increase from the same period in 2019, he said.

“Telehealth is here to stay, so the questions are how to craft a hospitalist telehealth program and provide essential patient care,” he said.

Dr. Timpe shared some examples of the evolution of telehealth care during the pandemic, including a case of an asymptomatic but frail patient with diabetes, dementia, and coronary artery disease undergoing outpatient care for a foot infection. The patient presented to an emergency department but refused to be hospitalized because of family concerns about patient isolation (no visitors were allowed at the time) and the concerns about COVID-19 infection.

The need to help treat acutely ill patients such as this patient while avoiding hospital admission during and after the pandemic continues to lead to the development of telehealth programs, Dr. Timpe said. She shared details of the Hospital@Home program developed by her organization, Health Partners. The program is designed to treat acutely ill people in the home, if possible, and avoid the need for hospital admission. Patients receive daily medical management from a hospitalist and care from staff, including registered nurses and community paramedics. Services include provision of IV medications and fluids, but the staff also conduct labs and imaging services, Dr. Timpe said.

Conditions that the program has managed at patients’ homes include pneumonia, COPD, asthma, bronchitis, flu, COVID-19, congestive heart failure, cellulitis, and urinary tract infections, said Dr. Timpe.

“We do not accept people into the program who have treatment needs that can only be met in a hospital,” such as the need for blood products, vasopressor support, telemetry, or positive pressure support, she noted.

Between November 2019 and February 15, 2021, the Hospital@Home program has provided services to 132 patients for a total of 287 visits. The program has averted 50 emergency department visits and 40 hospitalizations, and shorted hospital stays in 57 cases, she noted.

Hospitalists are suited for telehealth for several reasons, including the ability to triage acutely ill patients, familiarity with resource utilization, and expertise in management of complex medical care, said Dr. Timpe.
 

Looking ahead

Dr. Doshi emphasized several ongoing issues regarding the future of telemedicine, primarily the need for standardized regulation and reimbursement; reduction of health equity disparity and attention to technological barriers (including access and technology literacy); and identification of the next frontiers in telehealth.

Research on the impact and effectiveness of telehealth is limited, but growing, and next frontiers might include making patients more active participants in telehealth via patient-operated kits, or the option of an open telemedicine marketplace, in which patients can select providers from across the country, he said. No matter where telehealth leads in the future, “we need to make sure we have a positive patient outcome,” he concluded.

Dr. Doshi and Dr. Timpe had no financial conflicts to disclose.

More than 11 million individuals in the United States identify as LGBTQ+, and data show that this population has a shorter life expectancy and increased rates of suicide, violence, and cardiovascular disease, according to Keshav Khanijow, MD, of Northwestern University, Chicago, and Nicole Rosendale, MD, of the University of California, San Francisco.

More than half of these individuals report experiencing discrimination, and one in three transgendered individuals have reported prejudice when visiting a doctor or health clinic, they said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

“It is impossible to know how someone identifies by gender just by looking at them,” Dr. Rosendale emphasized.

However, attention to terminology, use of affirming language and documentation, and attention to clinical considerations can help LGBTQ+ patients feel comfortable in the health care setting.
 

Ask, don’t assume

Do ask patients how they identify themselves, Dr. Khanijow said. It is important to ask about sexual orientation as part of a social history. One big “Don’t” in terminology is to avoid the use of the term “homosexual,” he added. Although the description “homosexual” began as a scientific term, it has become associated with pathology, rather than identity, and is often used by hate groups. Also, do not assume sexual orientation based on a patient’s partner.

Always ask about sexual orientation before assuming it, and include that information in documentation. Dr. Khanijow used an example of a “one-liner” case of a 45-year-old male who self-identifies as “queer” and presents with a migraine. The most appropriate version would be “45yoM who identifies as queer with PMHx Migraines presents with Headache,” Dr. Khanijow said. However, as a clinician, consider why you are including sexual orientation in the one-liner. If there isn’t any real reason to include it (such as stress related to coming out, increased risk for other conditions) it may not be necessary in all visits.
 

Transgender considerations

Dr. Khanijow shared some specific considerations for the transgender/nonbinary population.

In terms of gender, “it is most respectful to identify the patient as they would like to be identified,” he said.

Ask how they identify their gender, including their preferred pronouns, and be sure to note this identification in their documents, he said. Be vigilant in addressing a transgender patient correctly. Mistakes happen, and when they do, correct yourself, apologize succinctly and move on.
 

Clinical challenges

Research on LGBTQ+ health is limited, and these individuals are often grouped into a single category despite diverse experiences, Dr. Rosendale said. Another limitation in LGBTQ+ research is that some studies assess based on identity (such as gay, lesbian, bisexual) while others assess behavior (studies of men who have sex with men).

Dr. Rosendale went on to highlight several important clinical concerns for the LGBTQ+ population. Compared with the general population, lesbian women are at higher risk for breast cancer, and gay men are at increased risk for prostate, colon, and testicular cancers. Potential heart disease risk factors of physical inactivity, obesity, and smoking are more prevalent among lesbian women, and tobacco and alcohol use are more prevalent among gay men, and men who have sex with men are at increased risk for STIs.

Clinicians also should be aware that “bisexual individuals face worse health outcomes than their lesbian, gay, and heterosexual counterparts,” Dr. Rosendale said.

LGBTQ+ patients often use hormone therapy, so clinicians should be aware of some potential adverse effects, Dr. Rosendale said. For example, trans women on gender-affirming estrogen therapy may have increased cardiovascular risks including incident MI, ischemic stroke, and cardiovascular mortality, compared with cisgender women.

In trans men, testosterone use has not been definitively linked to cardiovascular risk, although patients may show small changes in systolic blood pressure, lipid profiles, and blood glucose, Dr. Rosendale noted.
 

In-hospital issues

Inpatient and critical care of transgender and LGBTQ+ patients may have unique psychosocial considerations in hospital care, Dr. Rosendale said. To provide some guidance, a document on “Transgender-Affirming Hospital Policies” has been developed jointly by Lamda Legal, the Human Rights Campaign, the law firm of Hogan Lovells, and the New York City Bar.

Best practices noted in the document include rooming transgender individuals according to their identity, and recognizing that these patients may experience additional stress while an inpatient if personal clothing or other means of gender expression are replaced during the hospital stay, Dr. Rosendale noted.

Finally, clinicians seeing LGBTQ+ patients in an acute care setting should keep in mind that socioeconomic disparities may limit access to outpatient care, and that this population has higher rates of unemployment, exacerbated by the ongoing COVID-19 pandemic, Dr. Rosendale said. In addition, she advised clinicians to be aware that LGBTQ+ people may experience discrimination in rehabilitation centers, and their surrogate decision makers may be individuals other than family members.

Dr. Khanijow and Dr. Rosendale had no financial conflicts to disclose.

More than 11 million individuals in the United States identify as LGBTQ+, and data show that this population has a shorter life expectancy and increased rates of suicide, violence, and cardiovascular disease, according to Keshav Khanijow, MD, of Northwestern University, Chicago, and Nicole Rosendale, MD, of the University of California, San Francisco.

More than half of these individuals report experiencing discrimination, and one in three transgendered individuals have reported prejudice when visiting a doctor or health clinic, they said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

“It is impossible to know how someone identifies by gender just by looking at them,” Dr. Rosendale emphasized.

However, attention to terminology, use of affirming language and documentation, and attention to clinical considerations can help LGBTQ+ patients feel comfortable in the health care setting.
 

Ask, don’t assume

Do ask patients how they identify themselves, Dr. Khanijow said. It is important to ask about sexual orientation as part of a social history. One big “Don’t” in terminology is to avoid the use of the term “homosexual,” he added. Although the description “homosexual” began as a scientific term, it has become associated with pathology, rather than identity, and is often used by hate groups. Also, do not assume sexual orientation based on a patient’s partner.

Always ask about sexual orientation before assuming it, and include that information in documentation. Dr. Khanijow used an example of a “one-liner” case of a 45-year-old male who self-identifies as “queer” and presents with a migraine. The most appropriate version would be “45yoM who identifies as queer with PMHx Migraines presents with Headache,” Dr. Khanijow said. However, as a clinician, consider why you are including sexual orientation in the one-liner. If there isn’t any real reason to include it (such as stress related to coming out, increased risk for other conditions) it may not be necessary in all visits.
 

Transgender considerations

Dr. Khanijow shared some specific considerations for the transgender/nonbinary population.

In terms of gender, “it is most respectful to identify the patient as they would like to be identified,” he said.

Ask how they identify their gender, including their preferred pronouns, and be sure to note this identification in their documents, he said. Be vigilant in addressing a transgender patient correctly. Mistakes happen, and when they do, correct yourself, apologize succinctly and move on.
 

Clinical challenges

Research on LGBTQ+ health is limited, and these individuals are often grouped into a single category despite diverse experiences, Dr. Rosendale said. Another limitation in LGBTQ+ research is that some studies assess based on identity (such as gay, lesbian, bisexual) while others assess behavior (studies of men who have sex with men).

Dr. Rosendale went on to highlight several important clinical concerns for the LGBTQ+ population. Compared with the general population, lesbian women are at higher risk for breast cancer, and gay men are at increased risk for prostate, colon, and testicular cancers. Potential heart disease risk factors of physical inactivity, obesity, and smoking are more prevalent among lesbian women, and tobacco and alcohol use are more prevalent among gay men, and men who have sex with men are at increased risk for STIs.

Clinicians also should be aware that “bisexual individuals face worse health outcomes than their lesbian, gay, and heterosexual counterparts,” Dr. Rosendale said.

LGBTQ+ patients often use hormone therapy, so clinicians should be aware of some potential adverse effects, Dr. Rosendale said. For example, trans women on gender-affirming estrogen therapy may have increased cardiovascular risks including incident MI, ischemic stroke, and cardiovascular mortality, compared with cisgender women.

In trans men, testosterone use has not been definitively linked to cardiovascular risk, although patients may show small changes in systolic blood pressure, lipid profiles, and blood glucose, Dr. Rosendale noted.
 

In-hospital issues

Inpatient and critical care of transgender and LGBTQ+ patients may have unique psychosocial considerations in hospital care, Dr. Rosendale said. To provide some guidance, a document on “Transgender-Affirming Hospital Policies” has been developed jointly by Lamda Legal, the Human Rights Campaign, the law firm of Hogan Lovells, and the New York City Bar.

Best practices noted in the document include rooming transgender individuals according to their identity, and recognizing that these patients may experience additional stress while an inpatient if personal clothing or other means of gender expression are replaced during the hospital stay, Dr. Rosendale noted.

Finally, clinicians seeing LGBTQ+ patients in an acute care setting should keep in mind that socioeconomic disparities may limit access to outpatient care, and that this population has higher rates of unemployment, exacerbated by the ongoing COVID-19 pandemic, Dr. Rosendale said. In addition, she advised clinicians to be aware that LGBTQ+ people may experience discrimination in rehabilitation centers, and their surrogate decision makers may be individuals other than family members.

Dr. Khanijow and Dr. Rosendale had no financial conflicts to disclose.

More than 11 million individuals in the United States identify as LGBTQ+, and data show that this population has a shorter life expectancy and increased rates of suicide, violence, and cardiovascular disease, according to Keshav Khanijow, MD, of Northwestern University, Chicago, and Nicole Rosendale, MD, of the University of California, San Francisco.

More than half of these individuals report experiencing discrimination, and one in three transgendered individuals have reported prejudice when visiting a doctor or health clinic, they said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

“It is impossible to know how someone identifies by gender just by looking at them,” Dr. Rosendale emphasized.

However, attention to terminology, use of affirming language and documentation, and attention to clinical considerations can help LGBTQ+ patients feel comfortable in the health care setting.
 

Ask, don’t assume

Do ask patients how they identify themselves, Dr. Khanijow said. It is important to ask about sexual orientation as part of a social history. One big “Don’t” in terminology is to avoid the use of the term “homosexual,” he added. Although the description “homosexual” began as a scientific term, it has become associated with pathology, rather than identity, and is often used by hate groups. Also, do not assume sexual orientation based on a patient’s partner.

Always ask about sexual orientation before assuming it, and include that information in documentation. Dr. Khanijow used an example of a “one-liner” case of a 45-year-old male who self-identifies as “queer” and presents with a migraine. The most appropriate version would be “45yoM who identifies as queer with PMHx Migraines presents with Headache,” Dr. Khanijow said. However, as a clinician, consider why you are including sexual orientation in the one-liner. If there isn’t any real reason to include it (such as stress related to coming out, increased risk for other conditions) it may not be necessary in all visits.
 

Transgender considerations

Dr. Khanijow shared some specific considerations for the transgender/nonbinary population.

In terms of gender, “it is most respectful to identify the patient as they would like to be identified,” he said.

Ask how they identify their gender, including their preferred pronouns, and be sure to note this identification in their documents, he said. Be vigilant in addressing a transgender patient correctly. Mistakes happen, and when they do, correct yourself, apologize succinctly and move on.
 

Clinical challenges

Research on LGBTQ+ health is limited, and these individuals are often grouped into a single category despite diverse experiences, Dr. Rosendale said. Another limitation in LGBTQ+ research is that some studies assess based on identity (such as gay, lesbian, bisexual) while others assess behavior (studies of men who have sex with men).

Dr. Rosendale went on to highlight several important clinical concerns for the LGBTQ+ population. Compared with the general population, lesbian women are at higher risk for breast cancer, and gay men are at increased risk for prostate, colon, and testicular cancers. Potential heart disease risk factors of physical inactivity, obesity, and smoking are more prevalent among lesbian women, and tobacco and alcohol use are more prevalent among gay men, and men who have sex with men are at increased risk for STIs.

Clinicians also should be aware that “bisexual individuals face worse health outcomes than their lesbian, gay, and heterosexual counterparts,” Dr. Rosendale said.

LGBTQ+ patients often use hormone therapy, so clinicians should be aware of some potential adverse effects, Dr. Rosendale said. For example, trans women on gender-affirming estrogen therapy may have increased cardiovascular risks including incident MI, ischemic stroke, and cardiovascular mortality, compared with cisgender women.

In trans men, testosterone use has not been definitively linked to cardiovascular risk, although patients may show small changes in systolic blood pressure, lipid profiles, and blood glucose, Dr. Rosendale noted.
 

In-hospital issues

Inpatient and critical care of transgender and LGBTQ+ patients may have unique psychosocial considerations in hospital care, Dr. Rosendale said. To provide some guidance, a document on “Transgender-Affirming Hospital Policies” has been developed jointly by Lamda Legal, the Human Rights Campaign, the law firm of Hogan Lovells, and the New York City Bar.

Best practices noted in the document include rooming transgender individuals according to their identity, and recognizing that these patients may experience additional stress while an inpatient if personal clothing or other means of gender expression are replaced during the hospital stay, Dr. Rosendale noted.

Finally, clinicians seeing LGBTQ+ patients in an acute care setting should keep in mind that socioeconomic disparities may limit access to outpatient care, and that this population has higher rates of unemployment, exacerbated by the ongoing COVID-19 pandemic, Dr. Rosendale said. In addition, she advised clinicians to be aware that LGBTQ+ people may experience discrimination in rehabilitation centers, and their surrogate decision makers may be individuals other than family members.

Dr. Khanijow and Dr. Rosendale had no financial conflicts to disclose.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.

A year into the COVID-19 pandemic, it is fair to say that children do transmit the virus, but at lower rates, Philip Zachariah, MD, of Columbia University, New York, said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

Supportive care remains a key element in treating children with COVID-19, Dr. Zachariah emphasized. His presentation on pediatric hot topics in COVID-19 addressed several issues including the importance of risk stratification, current therapeutic options, and the latest on multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19.
 

Recognize the high-risk patient

When it comes to identifying risk factors for COVID-19 in children, remember that the trajectory of disease is diverse, Dr. Zachariah said.

The presentations of COVID-19 in children include those who are older and/or have comorbidities and present with mainly respiratory issues, those who are younger with symptoms that might overlap with Kawasaki disease, and those who are older with symptoms of cardiac involvement and MIS-C.

The overall hospitalization rate for children with COVID-19 is approximately 5%, but once hospitalized, the rates of ICU admission are approximately 30% and reflect rates seen in adult patients, Dr. Zachariah noted.

In general, data show that underlying conditions are more common in acute COVID-19 cases, and laboratory anomalies are more pronounced in patients with MIS-C, he said.

Based on the most recent studies, independent risk factors for acute COVID-19 in children include extremes of age (infancy or adolescence), minority populations, obesity, medical complexity, immune compromise, and asthma.

However, data are limited on specific issues of medical complexity, and risk depends on the level and type of immunosuppression, as morbidity and mortality have been relatively low in transplant patients, Dr. Zachariah noted.

Another dilemma lies in recognizing MIS-C in a febrile child, Dr. Zachariah noted. A complex question, “but persistent high fever in the setting of known recent COVID-19 infections (within 3 to 6 weeks) seems key,” he said. “If given the chance to do one blood test, I would suggest doing a CRP [C-reactive protein] as a screening test,” Dr. Zachariah said. The best laboratory prognosticators appear to be lymphopenia and brain natriuretic peptide (BNP) he added.

A final risk factor is innate immune defects that might predispose previously healthy children to severe acute COVID-19, such as differences in cytokine expression, said Dr. Zachariah.

“For example, autoantibodies against type 1 interferon production may dispose to severe disease,” he noted. Patients with MIS-C have shown patterns of T-cell activation similar to those seen in severely ill adults, and activation of vascular patrolling CX3CR1+ CD8 + T cells appears as a distinguishing feature in MIS-C, he explained.
 

Prevention plans with monoclonal antibodies

Another hot topic in pediatric COVID-19 is the prevention of severe disease and hospitalization using the currently available therapies, Dr. Zachariah said. However, when interpreting efficacy data, clinicians are almost always extrapolating relative risk to absolute risk in children, he noted.

“Convalescent plasma was promising, but the data on efficacy are increasingly negative,” he noted. Instead, a more exciting development is the use of monoclonal antibodies, which, ideally, “will deliver protection to ‘high risk’ populations in the very early stages of infection,” he said.

Bamlanivimab/etesevimab is “a neutralizing IgG1 monoclonal antibody that binds to overlapping domains of the receptor binding domain of the spike protein of SARS-CoV-2,” said Dr. Zachariah. In a study of 1,035 patients with a median age of 56 years, a single intravenous infusion of bamlanivimab plus etesevimab within 3 days of a positive COVID-19 test showed a 70% reduction in risk of COVID-19 hospitalizations or death.

For children, the current Food and Drug Administration Emergency Use Authorization for monoclonal antibody use covers patients aged 12-17 years, who weigh 40 kg or more, and meet any of several other criteria: a body mass index at the 85th percentile or higher, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders such as cerebral palsy, chronic respiratory disease requiring daily control, diabetes, or chronic kidney disease, Dr. Zachariah said.

In addition, pediatric patients aged 12-17 years could be considered for monoclonal antibody treatment in consultation with a pediatric infectious disease specialist if they are symptomatic with COVID-19, weigh at least 40 kg, are not hospitalized for COVID-19 symptoms, and have no new oxygen requirements, he said.
 

More on MIS-C

Currently, IVIG is the most common treatment for MIS-C in the United States, Dr. Zachariah said. In addition, a study published in JAMA Feb. 1, 2021, showed that IVIG in combination with methylprednisolone was associated with a lower risk of treatment failure compared to IVIG alone in 111 children with a median age of 8.6 years.

Although comparative effectiveness data are lacking, in long-term follow-up, all the patients seemed to be doing fine, Dr. Zachariah said. Potential second-line therapies for atypical MIS-C include anakinra and tocilizumab, he added.

Dr. Zachariah concluded by emphasizing the potential of COVID-19 vaccines, with studies underway for both Moderna and Pfizer vaccines in children younger than 16 years.

Dr. Zachariah had no relevant financial conflicts to disclose.

A year into the COVID-19 pandemic, it is fair to say that children do transmit the virus, but at lower rates, Philip Zachariah, MD, of Columbia University, New York, said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

Supportive care remains a key element in treating children with COVID-19, Dr. Zachariah emphasized. His presentation on pediatric hot topics in COVID-19 addressed several issues including the importance of risk stratification, current therapeutic options, and the latest on multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19.
 

Recognize the high-risk patient

When it comes to identifying risk factors for COVID-19 in children, remember that the trajectory of disease is diverse, Dr. Zachariah said.

The presentations of COVID-19 in children include those who are older and/or have comorbidities and present with mainly respiratory issues, those who are younger with symptoms that might overlap with Kawasaki disease, and those who are older with symptoms of cardiac involvement and MIS-C.

The overall hospitalization rate for children with COVID-19 is approximately 5%, but once hospitalized, the rates of ICU admission are approximately 30% and reflect rates seen in adult patients, Dr. Zachariah noted.

In general, data show that underlying conditions are more common in acute COVID-19 cases, and laboratory anomalies are more pronounced in patients with MIS-C, he said.

Based on the most recent studies, independent risk factors for acute COVID-19 in children include extremes of age (infancy or adolescence), minority populations, obesity, medical complexity, immune compromise, and asthma.

However, data are limited on specific issues of medical complexity, and risk depends on the level and type of immunosuppression, as morbidity and mortality have been relatively low in transplant patients, Dr. Zachariah noted.

Another dilemma lies in recognizing MIS-C in a febrile child, Dr. Zachariah noted. A complex question, “but persistent high fever in the setting of known recent COVID-19 infections (within 3 to 6 weeks) seems key,” he said. “If given the chance to do one blood test, I would suggest doing a CRP [C-reactive protein] as a screening test,” Dr. Zachariah said. The best laboratory prognosticators appear to be lymphopenia and brain natriuretic peptide (BNP) he added.

A final risk factor is innate immune defects that might predispose previously healthy children to severe acute COVID-19, such as differences in cytokine expression, said Dr. Zachariah.

“For example, autoantibodies against type 1 interferon production may dispose to severe disease,” he noted. Patients with MIS-C have shown patterns of T-cell activation similar to those seen in severely ill adults, and activation of vascular patrolling CX3CR1+ CD8 + T cells appears as a distinguishing feature in MIS-C, he explained.
 

Prevention plans with monoclonal antibodies

Another hot topic in pediatric COVID-19 is the prevention of severe disease and hospitalization using the currently available therapies, Dr. Zachariah said. However, when interpreting efficacy data, clinicians are almost always extrapolating relative risk to absolute risk in children, he noted.

“Convalescent plasma was promising, but the data on efficacy are increasingly negative,” he noted. Instead, a more exciting development is the use of monoclonal antibodies, which, ideally, “will deliver protection to ‘high risk’ populations in the very early stages of infection,” he said.

Bamlanivimab/etesevimab is “a neutralizing IgG1 monoclonal antibody that binds to overlapping domains of the receptor binding domain of the spike protein of SARS-CoV-2,” said Dr. Zachariah. In a study of 1,035 patients with a median age of 56 years, a single intravenous infusion of bamlanivimab plus etesevimab within 3 days of a positive COVID-19 test showed a 70% reduction in risk of COVID-19 hospitalizations or death.

For children, the current Food and Drug Administration Emergency Use Authorization for monoclonal antibody use covers patients aged 12-17 years, who weigh 40 kg or more, and meet any of several other criteria: a body mass index at the 85th percentile or higher, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders such as cerebral palsy, chronic respiratory disease requiring daily control, diabetes, or chronic kidney disease, Dr. Zachariah said.

In addition, pediatric patients aged 12-17 years could be considered for monoclonal antibody treatment in consultation with a pediatric infectious disease specialist if they are symptomatic with COVID-19, weigh at least 40 kg, are not hospitalized for COVID-19 symptoms, and have no new oxygen requirements, he said.
 

More on MIS-C

Currently, IVIG is the most common treatment for MIS-C in the United States, Dr. Zachariah said. In addition, a study published in JAMA Feb. 1, 2021, showed that IVIG in combination with methylprednisolone was associated with a lower risk of treatment failure compared to IVIG alone in 111 children with a median age of 8.6 years.

Although comparative effectiveness data are lacking, in long-term follow-up, all the patients seemed to be doing fine, Dr. Zachariah said. Potential second-line therapies for atypical MIS-C include anakinra and tocilizumab, he added.

Dr. Zachariah concluded by emphasizing the potential of COVID-19 vaccines, with studies underway for both Moderna and Pfizer vaccines in children younger than 16 years.

Dr. Zachariah had no relevant financial conflicts to disclose.

A year into the COVID-19 pandemic, it is fair to say that children do transmit the virus, but at lower rates, Philip Zachariah, MD, of Columbia University, New York, said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine.

Supportive care remains a key element in treating children with COVID-19, Dr. Zachariah emphasized. His presentation on pediatric hot topics in COVID-19 addressed several issues including the importance of risk stratification, current therapeutic options, and the latest on multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19.
 

Recognize the high-risk patient

When it comes to identifying risk factors for COVID-19 in children, remember that the trajectory of disease is diverse, Dr. Zachariah said.

The presentations of COVID-19 in children include those who are older and/or have comorbidities and present with mainly respiratory issues, those who are younger with symptoms that might overlap with Kawasaki disease, and those who are older with symptoms of cardiac involvement and MIS-C.

The overall hospitalization rate for children with COVID-19 is approximately 5%, but once hospitalized, the rates of ICU admission are approximately 30% and reflect rates seen in adult patients, Dr. Zachariah noted.

In general, data show that underlying conditions are more common in acute COVID-19 cases, and laboratory anomalies are more pronounced in patients with MIS-C, he said.

Based on the most recent studies, independent risk factors for acute COVID-19 in children include extremes of age (infancy or adolescence), minority populations, obesity, medical complexity, immune compromise, and asthma.

However, data are limited on specific issues of medical complexity, and risk depends on the level and type of immunosuppression, as morbidity and mortality have been relatively low in transplant patients, Dr. Zachariah noted.

Another dilemma lies in recognizing MIS-C in a febrile child, Dr. Zachariah noted. A complex question, “but persistent high fever in the setting of known recent COVID-19 infections (within 3 to 6 weeks) seems key,” he said. “If given the chance to do one blood test, I would suggest doing a CRP [C-reactive protein] as a screening test,” Dr. Zachariah said. The best laboratory prognosticators appear to be lymphopenia and brain natriuretic peptide (BNP) he added.

A final risk factor is innate immune defects that might predispose previously healthy children to severe acute COVID-19, such as differences in cytokine expression, said Dr. Zachariah.

“For example, autoantibodies against type 1 interferon production may dispose to severe disease,” he noted. Patients with MIS-C have shown patterns of T-cell activation similar to those seen in severely ill adults, and activation of vascular patrolling CX3CR1+ CD8 + T cells appears as a distinguishing feature in MIS-C, he explained.
 

Prevention plans with monoclonal antibodies

Another hot topic in pediatric COVID-19 is the prevention of severe disease and hospitalization using the currently available therapies, Dr. Zachariah said. However, when interpreting efficacy data, clinicians are almost always extrapolating relative risk to absolute risk in children, he noted.

“Convalescent plasma was promising, but the data on efficacy are increasingly negative,” he noted. Instead, a more exciting development is the use of monoclonal antibodies, which, ideally, “will deliver protection to ‘high risk’ populations in the very early stages of infection,” he said.

Bamlanivimab/etesevimab is “a neutralizing IgG1 monoclonal antibody that binds to overlapping domains of the receptor binding domain of the spike protein of SARS-CoV-2,” said Dr. Zachariah. In a study of 1,035 patients with a median age of 56 years, a single intravenous infusion of bamlanivimab plus etesevimab within 3 days of a positive COVID-19 test showed a 70% reduction in risk of COVID-19 hospitalizations or death.

For children, the current Food and Drug Administration Emergency Use Authorization for monoclonal antibody use covers patients aged 12-17 years, who weigh 40 kg or more, and meet any of several other criteria: a body mass index at the 85th percentile or higher, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders such as cerebral palsy, chronic respiratory disease requiring daily control, diabetes, or chronic kidney disease, Dr. Zachariah said.

In addition, pediatric patients aged 12-17 years could be considered for monoclonal antibody treatment in consultation with a pediatric infectious disease specialist if they are symptomatic with COVID-19, weigh at least 40 kg, are not hospitalized for COVID-19 symptoms, and have no new oxygen requirements, he said.
 

More on MIS-C

Currently, IVIG is the most common treatment for MIS-C in the United States, Dr. Zachariah said. In addition, a study published in JAMA Feb. 1, 2021, showed that IVIG in combination with methylprednisolone was associated with a lower risk of treatment failure compared to IVIG alone in 111 children with a median age of 8.6 years.

Although comparative effectiveness data are lacking, in long-term follow-up, all the patients seemed to be doing fine, Dr. Zachariah said. Potential second-line therapies for atypical MIS-C include anakinra and tocilizumab, he added.

Dr. Zachariah concluded by emphasizing the potential of COVID-19 vaccines, with studies underway for both Moderna and Pfizer vaccines in children younger than 16 years.

Dr. Zachariah had no relevant financial conflicts to disclose.

As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.

In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.

Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
 

Referendum on remdesivir

The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).

“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.

The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.

Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.

In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”

Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.

Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.

Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
 

Taking on tocilizumab

Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.

Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.

Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.

By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.

Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).

He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.

Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.

Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.

Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.

Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.

As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.

In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.

Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
 

Referendum on remdesivir

The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).

“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.

The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.

Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.

In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”

Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.

Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.

Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
 

Taking on tocilizumab

Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.

Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.

Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.

By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.

Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).

He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.

Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.

Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.

Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.

Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.

As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.

In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.

Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
 

Referendum on remdesivir

The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).

“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.

The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.

Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.

In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”

Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.

Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.

Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
 

Taking on tocilizumab

Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.

Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.

Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.

By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.

Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).

He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.

Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.

Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.

Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.

Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

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Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.