News

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the annual Gut Microbiota for Health World Summit.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting, sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility. “The answer now is totally yes.”
 

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), he said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two poised for phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroidia and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with UC who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.
 

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vendata, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

In assessing and managing patients presenting with acute, life-threatening asthma, if the exacerbation does not resolve relatively quickly, clinicians need to start looking for other causes of the patient’s respiratory distress, a review of the literature suggests.

“I think one of the most important points of this review is that asthma is a self-limiting disease, and it’s important to understand that with appropriate treatment and immediate response to it, exacerbations will get better with time,” Orlando Garner, MD, Baylor College of Medicine, Houston, said in an interview.

“So I think one of the key points is, if these exacerbations do not resolve within 24-48 hours, clinicians need to start thinking: ‘This could be something else,’ and not get stuck in the diagnosis that this is an asthmatic patient who is having an exacerbation. If the distress doesn’t resolve within 48 hours, it’s time to look for other clues,” he stressed.

The study was published online in the journal CHEST^®.

Appropriate triage

Appropriate triage is key in the management of acute asthma, Dr. Garner and colleagues pointed out. A simplified severity score for the evaluation of asthma in the ED can help in this regard. Depending on the presence or absence of a number of key signs and symptoms, patients can be readily categorized as having mild, moderate, or severe asthma. “Static assessments and dynamic assessments of acute asthma exacerbation in the ED can also help triage patients,” the authors added.

Static assessment involves assessing the severity at presentation, which in turn determines the aggressiveness of initial treatment. Objective static assessments include the measurement of peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV₁). A severe exacerbation is usually defined as a PEF or an FEV₁ of less than 50%-60% of predicted normal values, the authors noted.

Dynamic assessment is more helpful than static assessment because it gauges response to treatment. “A lack of improvement in expiratory flow rates after initial bronchodilator therapy with continuous or worsening symptoms suggests need for hospitalization,” Dr. Garner and colleagues observed. The main treatment goals for patients with acute asthma are reversal of bronchospasm and correction of hypoxemia.

These are achieved at least initially with conventional agents, such as repeated doses of inhaled short-acting beta₂-agonists, inhaled short-acting anticholinergics, systemic corticosteroids, and occasionally intravenous magnesium sulfate. If there is concomitant hypoxemia, oxygen therapy should be initiated as well. Patients who have evidence of hypercapnic respiratory failure or diaphragmatic fatigue need to be admitted to the intensive care unit, the authors indicated.

For these patients, clinicians need to remember that there are therapies other than inhalers, such as epinephrine and systemic terbutaline. During a life-threatening asthma episode, airflow in the medium and small airways often becomes turbulent, increasing the work of breathing, the researchers pointed out.

Heliox, a combination of helium and oxygen, reduces turbulent flow, they noted, although FiO₂ requirements need to be less than 30% in order for it to work. “Heliox can be used in patients with severe bronchospasm who do not respond to the conventional therapies,” the authors noted, “[but] therapy should be abandoned if there is no clinical improvement after 15 minutes of use.”

Although none of the biologics such as dupilumab (Dupixent) has yet been approved for the treatment of acute exacerbations, Dr. Garner predicts they will become the “future of medicine” for patients with severe asthma as well.
 

Ventilation in life-threatening asthma

Rapid sequence intubation is generally recommended for patients who require mechanical ventilation, but as an alternative, “we are advocating a slower approach, where we get patients to slow down their breathing and relax them with something like ketamine infusions and wait before we given them a paralytic to see if the work of breathing improves,” Dr. Garner said. Bag-mask ventilation should be avoided because it can worsen dynamic hyperinflation or cause barotrauma.

Salvage therapies such as the use of bronchoscopy with N-acetylcysteine instilled directly into the airway is another option in cases in which mucus plugging is considered to be the main driver of airflow limitation.

Asked to comment, Brit Long, MD, an emergency medicine physician at the Brooke Army Medical Center in San Antonio, Tex., felt the review was extremely useful and well done.

“We see these patients very frequently, and being able to assess them right away and get an accurate picture of what’s going on is very important,” he said in an interview. The one thing that is often more difficult, at least in the ED, is obtaining a PEF or the FEV₁ – “both very helpful if the patient can do them, but if the patient is critically ill, it’s more likely you will not be able to get those assessments, and if patients are speaking in one-word sentences and are working really hard to breathe, that’s a severe exacerbation, and they need immediate intervention.” Dr. Long also liked all the essential treatments the authors recommended that patients be given immediately, although he noted that Heliox is not going to be available in most EDs.

On the other hand, he agreed with the authors’ recommendation to take a slower approach to mechanical ventilation, if it is needed at all. “I try my best to absolutely avoid intubating these patients – you are not fixing the issue with mechanical ventilation, you are just creating further problems.

“And while I see the entire spectrum of asthma patients from very mild to severe patients, these authors did a good job in explaining what the goals of treatment are and what to do with the severe ones,” he said.

Dr. Garner and Dr. Long disclosed no relevant financial relationships.

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

In assessing and managing patients presenting with acute, life-threatening asthma, if the exacerbation does not resolve relatively quickly, clinicians need to start looking for other causes of the patient’s respiratory distress, a review of the literature suggests.

“I think one of the most important points of this review is that asthma is a self-limiting disease, and it’s important to understand that with appropriate treatment and immediate response to it, exacerbations will get better with time,” Orlando Garner, MD, Baylor College of Medicine, Houston, said in an interview.

“So I think one of the key points is, if these exacerbations do not resolve within 24-48 hours, clinicians need to start thinking: ‘This could be something else,’ and not get stuck in the diagnosis that this is an asthmatic patient who is having an exacerbation. If the distress doesn’t resolve within 48 hours, it’s time to look for other clues,” he stressed.

The study was published online in the journal CHEST^®.

Appropriate triage

Appropriate triage is key in the management of acute asthma, Dr. Garner and colleagues pointed out. A simplified severity score for the evaluation of asthma in the ED can help in this regard. Depending on the presence or absence of a number of key signs and symptoms, patients can be readily categorized as having mild, moderate, or severe asthma. “Static assessments and dynamic assessments of acute asthma exacerbation in the ED can also help triage patients,” the authors added.

Static assessment involves assessing the severity at presentation, which in turn determines the aggressiveness of initial treatment. Objective static assessments include the measurement of peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV₁). A severe exacerbation is usually defined as a PEF or an FEV₁ of less than 50%-60% of predicted normal values, the authors noted.

Dynamic assessment is more helpful than static assessment because it gauges response to treatment. “A lack of improvement in expiratory flow rates after initial bronchodilator therapy with continuous or worsening symptoms suggests need for hospitalization,” Dr. Garner and colleagues observed. The main treatment goals for patients with acute asthma are reversal of bronchospasm and correction of hypoxemia.

These are achieved at least initially with conventional agents, such as repeated doses of inhaled short-acting beta₂-agonists, inhaled short-acting anticholinergics, systemic corticosteroids, and occasionally intravenous magnesium sulfate. If there is concomitant hypoxemia, oxygen therapy should be initiated as well. Patients who have evidence of hypercapnic respiratory failure or diaphragmatic fatigue need to be admitted to the intensive care unit, the authors indicated.

For these patients, clinicians need to remember that there are therapies other than inhalers, such as epinephrine and systemic terbutaline. During a life-threatening asthma episode, airflow in the medium and small airways often becomes turbulent, increasing the work of breathing, the researchers pointed out.

Heliox, a combination of helium and oxygen, reduces turbulent flow, they noted, although FiO₂ requirements need to be less than 30% in order for it to work. “Heliox can be used in patients with severe bronchospasm who do not respond to the conventional therapies,” the authors noted, “[but] therapy should be abandoned if there is no clinical improvement after 15 minutes of use.”

Although none of the biologics such as dupilumab (Dupixent) has yet been approved for the treatment of acute exacerbations, Dr. Garner predicts they will become the “future of medicine” for patients with severe asthma as well.
 

Ventilation in life-threatening asthma

Rapid sequence intubation is generally recommended for patients who require mechanical ventilation, but as an alternative, “we are advocating a slower approach, where we get patients to slow down their breathing and relax them with something like ketamine infusions and wait before we given them a paralytic to see if the work of breathing improves,” Dr. Garner said. Bag-mask ventilation should be avoided because it can worsen dynamic hyperinflation or cause barotrauma.

Salvage therapies such as the use of bronchoscopy with N-acetylcysteine instilled directly into the airway is another option in cases in which mucus plugging is considered to be the main driver of airflow limitation.

Asked to comment, Brit Long, MD, an emergency medicine physician at the Brooke Army Medical Center in San Antonio, Tex., felt the review was extremely useful and well done.

“We see these patients very frequently, and being able to assess them right away and get an accurate picture of what’s going on is very important,” he said in an interview. The one thing that is often more difficult, at least in the ED, is obtaining a PEF or the FEV₁ – “both very helpful if the patient can do them, but if the patient is critically ill, it’s more likely you will not be able to get those assessments, and if patients are speaking in one-word sentences and are working really hard to breathe, that’s a severe exacerbation, and they need immediate intervention.” Dr. Long also liked all the essential treatments the authors recommended that patients be given immediately, although he noted that Heliox is not going to be available in most EDs.

On the other hand, he agreed with the authors’ recommendation to take a slower approach to mechanical ventilation, if it is needed at all. “I try my best to absolutely avoid intubating these patients – you are not fixing the issue with mechanical ventilation, you are just creating further problems.

“And while I see the entire spectrum of asthma patients from very mild to severe patients, these authors did a good job in explaining what the goals of treatment are and what to do with the severe ones,” he said.

Dr. Garner and Dr. Long disclosed no relevant financial relationships.

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

In assessing and managing patients presenting with acute, life-threatening asthma, if the exacerbation does not resolve relatively quickly, clinicians need to start looking for other causes of the patient’s respiratory distress, a review of the literature suggests.

“I think one of the most important points of this review is that asthma is a self-limiting disease, and it’s important to understand that with appropriate treatment and immediate response to it, exacerbations will get better with time,” Orlando Garner, MD, Baylor College of Medicine, Houston, said in an interview.

“So I think one of the key points is, if these exacerbations do not resolve within 24-48 hours, clinicians need to start thinking: ‘This could be something else,’ and not get stuck in the diagnosis that this is an asthmatic patient who is having an exacerbation. If the distress doesn’t resolve within 48 hours, it’s time to look for other clues,” he stressed.

The study was published online in the journal CHEST^®.

Appropriate triage

Appropriate triage is key in the management of acute asthma, Dr. Garner and colleagues pointed out. A simplified severity score for the evaluation of asthma in the ED can help in this regard. Depending on the presence or absence of a number of key signs and symptoms, patients can be readily categorized as having mild, moderate, or severe asthma. “Static assessments and dynamic assessments of acute asthma exacerbation in the ED can also help triage patients,” the authors added.

Static assessment involves assessing the severity at presentation, which in turn determines the aggressiveness of initial treatment. Objective static assessments include the measurement of peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV₁). A severe exacerbation is usually defined as a PEF or an FEV₁ of less than 50%-60% of predicted normal values, the authors noted.

Dynamic assessment is more helpful than static assessment because it gauges response to treatment. “A lack of improvement in expiratory flow rates after initial bronchodilator therapy with continuous or worsening symptoms suggests need for hospitalization,” Dr. Garner and colleagues observed. The main treatment goals for patients with acute asthma are reversal of bronchospasm and correction of hypoxemia.

These are achieved at least initially with conventional agents, such as repeated doses of inhaled short-acting beta₂-agonists, inhaled short-acting anticholinergics, systemic corticosteroids, and occasionally intravenous magnesium sulfate. If there is concomitant hypoxemia, oxygen therapy should be initiated as well. Patients who have evidence of hypercapnic respiratory failure or diaphragmatic fatigue need to be admitted to the intensive care unit, the authors indicated.

For these patients, clinicians need to remember that there are therapies other than inhalers, such as epinephrine and systemic terbutaline. During a life-threatening asthma episode, airflow in the medium and small airways often becomes turbulent, increasing the work of breathing, the researchers pointed out.

Heliox, a combination of helium and oxygen, reduces turbulent flow, they noted, although FiO₂ requirements need to be less than 30% in order for it to work. “Heliox can be used in patients with severe bronchospasm who do not respond to the conventional therapies,” the authors noted, “[but] therapy should be abandoned if there is no clinical improvement after 15 minutes of use.”

Although none of the biologics such as dupilumab (Dupixent) has yet been approved for the treatment of acute exacerbations, Dr. Garner predicts they will become the “future of medicine” for patients with severe asthma as well.
 

Ventilation in life-threatening asthma

Rapid sequence intubation is generally recommended for patients who require mechanical ventilation, but as an alternative, “we are advocating a slower approach, where we get patients to slow down their breathing and relax them with something like ketamine infusions and wait before we given them a paralytic to see if the work of breathing improves,” Dr. Garner said. Bag-mask ventilation should be avoided because it can worsen dynamic hyperinflation or cause barotrauma.

Salvage therapies such as the use of bronchoscopy with N-acetylcysteine instilled directly into the airway is another option in cases in which mucus plugging is considered to be the main driver of airflow limitation.

Asked to comment, Brit Long, MD, an emergency medicine physician at the Brooke Army Medical Center in San Antonio, Tex., felt the review was extremely useful and well done.

“We see these patients very frequently, and being able to assess them right away and get an accurate picture of what’s going on is very important,” he said in an interview. The one thing that is often more difficult, at least in the ED, is obtaining a PEF or the FEV₁ – “both very helpful if the patient can do them, but if the patient is critically ill, it’s more likely you will not be able to get those assessments, and if patients are speaking in one-word sentences and are working really hard to breathe, that’s a severe exacerbation, and they need immediate intervention.” Dr. Long also liked all the essential treatments the authors recommended that patients be given immediately, although he noted that Heliox is not going to be available in most EDs.

On the other hand, he agreed with the authors’ recommendation to take a slower approach to mechanical ventilation, if it is needed at all. “I try my best to absolutely avoid intubating these patients – you are not fixing the issue with mechanical ventilation, you are just creating further problems.

“And while I see the entire spectrum of asthma patients from very mild to severe patients, these authors did a good job in explaining what the goals of treatment are and what to do with the severe ones,” he said.

Dr. Garner and Dr. Long disclosed no relevant financial relationships.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

A version of this article first appeared on WebMD.com.

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

A version of this article first appeared on WebMD.com.

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

A version of this article first appeared on WebMD.com.

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

PHOENIX – Before considering oral steroids or biologic therapies, many people with difficult-to-control asthma can reduce symptoms by addressing medication adherence and inhaler technique – and digital monitoring devices can play a key role.

Often physicians “will approach a patient about a biologic if they’re not responding to standard therapy. But we need to sometimes go back to those basic building blocks, like, are you taking the standard therapy?” William C. Anderson, MD, codirector of the multidisciplinary asthma clinic at Children’s Hospital Colorado, Aurora, said in an interview.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunology, he and others presented data highlighting the diagnostic and therapeutic potential of digital monitoring devices for difficult-to-control asthma, the theme of the 2022s meeting.

The Global Initiative for Asthma (GINA) defines asthma as “difficult to control” if it remains uncontrolled despite medium- or high-dose inhaled corticosteroids with a second controller or with maintenance oral steroids, or if the asthma requires high-dose treatment to curb symptoms and exacerbations. About 17% of adult asthma patients have difficult-to-control asthma, according to the 2021 GINA report. 

However, correcting for inhaling technique and adherence cuts the 17% down to just 3.7%, Giselle Mosnaim, MD, an allergist at NorthShore University HealthSystem outside Chicago and AAAAI immediate past president, told attendees at a Feb. 25 session on digital technologies for asthma management.

The CRITIKAL study, which reviewed data from more than 5,000 asthma patients, “showed that, if you have critical errors in inhaler technique, this leads to worse asthma outcomes and increased asthma exacerbations,” Dr. Mosnaim said. Sadly, it also shows that, from 1975 to 2014, despite new devices and new technologies, “we still have poor inhaler technique.”

As for ways to measure adherence, physician judgments tend to be inaccurate, patient self-reporting has proved unreliable, and prescription refill data doesn’t indicate whether patients actually used the medications. “The ideal measure of adherence should be objective, accurate and unobtrusive to minimize impact on patient behavior and allow reliable data collection in real-world settings,” Dr. Mosnaim said. “So electronic medication monitors are the gold standard.” 
 

Tracking adherence

A closing afternoon session featured three presentations on research tracking adherence and outcomes in difficult-to-treat asthma patients – two pediatric cohorts and one across all ages. All studies used the Propeller Health sensor, a Food and Drug Administration–cleared device that attaches to the patient’s inhaler and automatically collects information on where, when, and how often they use their medication. The sensor then sends that information to a data cloud accessible to the patient and their health care professional.

Dr. Anderson’s team scoured a nationwide Propeller Health database for 8,000 patients using the digital monitors with controller therapies for asthma or chronic obstructive pulmonary disease (COPD). The study explored whether adherence differed for once-daily versus twice-daily medications, and if adherence differed based on patient age (4-60+ years).

For both asthma and COPD patients, those on once-daily regimens had higher medication adherence, compared with those who were prescribed twice-daily therapies. Plus, a greater proportion of once-daily patients met the prespecified 80% adherence threshold.

Looking across ages, medication use in the youngest group (aged 4-11 years) looked comparable with 30-somethings, “probably because parents are the ones giving the drug,” Dr. Anderson said. Mirroring patterns from other studies, adherence levels dipped in adolescents and young adults, relative to other age subsets.

Since this population-level analysis didn’t include individualized data on exacerbations or asthma control, “we can’t relate this to outcomes,” Dr. Anderson noted. But he said the data correlating medication use with adherence suggest that once-daily formulations may be the better option.

In one of the two pediatric studies, Matt McCulloch, MD, an allergy and immunology fellow working with Dr. Anderson, and colleagues reviewed charts of 40 children who received care at the Colorado Children’s multidisciplinary asthma clinic between 2018 and 2021. Half of these patients used Propeller Health sensors with their daily inhaled controller; the other patients were matched for age, ethnicity, sex, medication level, and disease control and severity – but had no electronic monitoring device.

On the whole, children who used digital monitoring for 12 months did not fare much better than matched controls on lung function (judged by forced expiratory volume) or asthma control (measured by Asthma Control Test scores).

However, within the digital monitoring group, patients who stayed on the Propeller system for 12 months did have better asthma control, fewer exacerbations, and improved asthma severity scores (measured by the Composite Asthma Severity Index), compared with when they first began digital monitoring. These children had all received care at the clinic for a while before their families opted for the electronic sensor, so “the effect wouldn’t have just been from starting in the clinic,” Dr. McCulloch said in an interview.

The gains came despite waning medication adherence. Similar to other digital monitoring studies, use of daily controller therapies in this retrospective analysis began at 50%-80% but dropped considerably during the first 4-5 months before settling into the 20%-30% range by 1 year.

Rachelle Ramsey, PhD, a pediatric research psychologist at Cincinnati Children’s Hospital Medical Center, presented data from 20 children with difficult-to-treat asthma who received 8 weeks of a digital adherence intervention during a 12-month treatment period. They analyzed three subsets – each with interventions based on how well the patients were managing daily controller therapy at baseline.

One patient with high (>80%) baseline adherence just received digital monitoring. The seven patients who began the study with intermediate (50%-80%) adherence received digital monitoring plus prescriptive text messaging. And the 12 children with poorest (<50%) baseline adherence received digital monitoring and a telehealth session in which a behavioral health specialist helped them set goals and create strategies to overcome barriers – for example, keeping the inhaler near their toothbrush in order to pair medication use with a daily habit.

“Overall, we found that matching Propeller with a behavioral intervention really improved adherence,” Dr. Ramsey said in an interview. While patients were receiving the intervention, adherence averaged across all groups increased from 39% to 76%. However, once the intervention period ended, the group’s adherence regressed toward baseline (36%).

Although adherence did not associate with clinical gains in this small study, the use of digital monitoring to improve medication adherence has translated to better outcomes in other recent efforts.
 

Remote monitoring

In a quality improvement project in the United Kingdom, nurses asked difficult-to-control asthma patients if they understood how to use their corticosteroid/long-acting beta₂-agonist (LABA) inhalers and if they were adhering to treatment guidelines.

Those who answered yes to these questions were invited to a 28-day study that involved swapping their steroid/LABA inhalers for a different controller/bronchodilator (fluticasone/salmeterol) with INCA (Inhaler Compliance Assessment), a device that not only tracks adherence but also uses acoustics to gauge inhaler technique.

Among the 23 patients who participated, many had better clinical outcomes after 28 days of INCA monitoring. As Dr. Mosnaim told attendees, “what was amazing is so many of the patients that had been these difficult-to-control asthmatics who would have gone on to oral steroids or perhaps a biologic – lo and behold, you put them on a digital inhaler, and what do you see?” In two-thirds of the patients, “you see FeNo [a test that measures airway inflammation by detecting nitric oxide in exhalations] goes down. You see spirometry improve. You see the asthma control questionnaire improve. You see blood eosinophils go down.”

And in a 2020 randomized trial, Dr. Mosnaim and colleagues recruited 100 adults with uncontrolled asthma who had prescriptions for a daily inhaled corticosteroid and a short-acting beta-agonist (SABA) inhaler. Participants received Propeller sensors for their steroid and SABA inhalers. After a 2-week run-in period to calculate baseline corticosteroid adherence and SABA use for all participants, half the participants were randomly assigned to the control group, which had the app and sensor in silent mode, merely to collect data on medication use – whereas the treatment group received reminders, alerts, and monthly phone calls from providers who gave feedback on adherence and technique.

After 3 months of digital monitoring, patients didn’t use their rescue medication quite as often – as judged by a rise in the percentage of SABA-free days, compared with when they began the study. But the change in SABA-free days relative to baseline was more pronounced in the treatment group (19%) than in the control group (6%).

As seen in the other digital monitoring studies, adherence to daily corticosteroids fell with time, but the drop was milder in treated participants (2%) versus the control group (17%). So in this study, digital monitoring plus mobile app reminders and clinician feedback “prevented against fall in adherence to inhaled steroids over time,” Dr. Mosnaim said.

These results are “very encouraging” and offer “proof of concept that this type of remote monitoring could work,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., said in an interview. One limitation was that the study was too short to measure exacerbation rates. A yearlong analysis would be “really fascinating because you’d catch all the seasons of the year – all the pollen seasons, all these things that could exacerbate you. Some people’s asthma can be quite seasonal.”

More important, the clinical utility of digital sensors will depend on how physicians choose to use them. If the doctor puts out a “blanket recommendation for using it but doesn’t ask you about it or doesn’t use the data to inform your care, then I think people just lose engagement and lose excitement over it,” Dr. Ramsey said. But if the health care team “asks you about the data or looks at the data with you or shows you how valuable this can be to your care, then I think that changes things.”

Building these analyses and interactions into the clinic workflow isn’t trivial. “If you have this wealth of data coming in, how are you going to look at it? Are you going to have an individual person assigned to this role? How are you going to respond to alerts?” Dr. Anderson asked.

In addition, because some digital monitors issue alerts when a patient’s asthma is not well controlled, some providers worry about liability if “something bad were to happen if you had that data but didn’t act upon it,” he said. Yet he noted that remote data monitoring is already used routinely in other areas of medicine, such as managing diabetes and heart conditions, “and it’s not like people are getting dinged for that stuff.”

Another issue is cost. Insurance only covers digital monitors in select cases, but it’s a bit of a catch-22. Insurers “don’t want to cover it until they get the data, but you can’t get the data until insurance covers it,” said Dr. Anderson, who added that “this year we finally got CPT reimbursement codes for monitoring devices.”

On the whole, studies of digital medication monitors suggest that better outcomes require “a good partnership between the health care provider and the patient,” Dr. Pongdee said. “It wasn’t like you could just put these things on and expect them to help. You still need that personal relationship to get the optimal results. We can have all this technology, but you still can’t take the people out of it.”

Dr. Mosnaim reported receiving current research grant support from GlaxoSmithKline, Novartis, Sanofi-Regeneron, and Teva; and past research grant support from AstraZeneca, Alk-Abello, and Genentech. She is immediate past president of the AAAAI, and directs the board of directors for the American Board of Allergy and Immunology. Dr. Anderson has served as a consultant for Regeneron, GlaxoSmithKline, and AstraZeneca, and has received research support from Colorado Medicaid. Dr. McCulloch and Dr. Ramsey disclosed no relevant financial relationships. Dr. Pongdee serves as an at-large director on the American Academy of Allergy, Asthma and Immunology board of directors. He receives grant funding from GlaxoSmithKline, and the Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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

PHOENIX – Before considering oral steroids or biologic therapies, many people with difficult-to-control asthma can reduce symptoms by addressing medication adherence and inhaler technique – and digital monitoring devices can play a key role.

Often physicians “will approach a patient about a biologic if they’re not responding to standard therapy. But we need to sometimes go back to those basic building blocks, like, are you taking the standard therapy?” William C. Anderson, MD, codirector of the multidisciplinary asthma clinic at Children’s Hospital Colorado, Aurora, said in an interview.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunology, he and others presented data highlighting the diagnostic and therapeutic potential of digital monitoring devices for difficult-to-control asthma, the theme of the 2022s meeting.

The Global Initiative for Asthma (GINA) defines asthma as “difficult to control” if it remains uncontrolled despite medium- or high-dose inhaled corticosteroids with a second controller or with maintenance oral steroids, or if the asthma requires high-dose treatment to curb symptoms and exacerbations. About 17% of adult asthma patients have difficult-to-control asthma, according to the 2021 GINA report. 

However, correcting for inhaling technique and adherence cuts the 17% down to just 3.7%, Giselle Mosnaim, MD, an allergist at NorthShore University HealthSystem outside Chicago and AAAAI immediate past president, told attendees at a Feb. 25 session on digital technologies for asthma management.

The CRITIKAL study, which reviewed data from more than 5,000 asthma patients, “showed that, if you have critical errors in inhaler technique, this leads to worse asthma outcomes and increased asthma exacerbations,” Dr. Mosnaim said. Sadly, it also shows that, from 1975 to 2014, despite new devices and new technologies, “we still have poor inhaler technique.”

As for ways to measure adherence, physician judgments tend to be inaccurate, patient self-reporting has proved unreliable, and prescription refill data doesn’t indicate whether patients actually used the medications. “The ideal measure of adherence should be objective, accurate and unobtrusive to minimize impact on patient behavior and allow reliable data collection in real-world settings,” Dr. Mosnaim said. “So electronic medication monitors are the gold standard.” 
 

Tracking adherence

A closing afternoon session featured three presentations on research tracking adherence and outcomes in difficult-to-treat asthma patients – two pediatric cohorts and one across all ages. All studies used the Propeller Health sensor, a Food and Drug Administration–cleared device that attaches to the patient’s inhaler and automatically collects information on where, when, and how often they use their medication. The sensor then sends that information to a data cloud accessible to the patient and their health care professional.

Dr. Anderson’s team scoured a nationwide Propeller Health database for 8,000 patients using the digital monitors with controller therapies for asthma or chronic obstructive pulmonary disease (COPD). The study explored whether adherence differed for once-daily versus twice-daily medications, and if adherence differed based on patient age (4-60+ years).

For both asthma and COPD patients, those on once-daily regimens had higher medication adherence, compared with those who were prescribed twice-daily therapies. Plus, a greater proportion of once-daily patients met the prespecified 80% adherence threshold.

Looking across ages, medication use in the youngest group (aged 4-11 years) looked comparable with 30-somethings, “probably because parents are the ones giving the drug,” Dr. Anderson said. Mirroring patterns from other studies, adherence levels dipped in adolescents and young adults, relative to other age subsets.

Since this population-level analysis didn’t include individualized data on exacerbations or asthma control, “we can’t relate this to outcomes,” Dr. Anderson noted. But he said the data correlating medication use with adherence suggest that once-daily formulations may be the better option.

In one of the two pediatric studies, Matt McCulloch, MD, an allergy and immunology fellow working with Dr. Anderson, and colleagues reviewed charts of 40 children who received care at the Colorado Children’s multidisciplinary asthma clinic between 2018 and 2021. Half of these patients used Propeller Health sensors with their daily inhaled controller; the other patients were matched for age, ethnicity, sex, medication level, and disease control and severity – but had no electronic monitoring device.

On the whole, children who used digital monitoring for 12 months did not fare much better than matched controls on lung function (judged by forced expiratory volume) or asthma control (measured by Asthma Control Test scores).

However, within the digital monitoring group, patients who stayed on the Propeller system for 12 months did have better asthma control, fewer exacerbations, and improved asthma severity scores (measured by the Composite Asthma Severity Index), compared with when they first began digital monitoring. These children had all received care at the clinic for a while before their families opted for the electronic sensor, so “the effect wouldn’t have just been from starting in the clinic,” Dr. McCulloch said in an interview.

The gains came despite waning medication adherence. Similar to other digital monitoring studies, use of daily controller therapies in this retrospective analysis began at 50%-80% but dropped considerably during the first 4-5 months before settling into the 20%-30% range by 1 year.

Rachelle Ramsey, PhD, a pediatric research psychologist at Cincinnati Children’s Hospital Medical Center, presented data from 20 children with difficult-to-treat asthma who received 8 weeks of a digital adherence intervention during a 12-month treatment period. They analyzed three subsets – each with interventions based on how well the patients were managing daily controller therapy at baseline.

One patient with high (>80%) baseline adherence just received digital monitoring. The seven patients who began the study with intermediate (50%-80%) adherence received digital monitoring plus prescriptive text messaging. And the 12 children with poorest (<50%) baseline adherence received digital monitoring and a telehealth session in which a behavioral health specialist helped them set goals and create strategies to overcome barriers – for example, keeping the inhaler near their toothbrush in order to pair medication use with a daily habit.

“Overall, we found that matching Propeller with a behavioral intervention really improved adherence,” Dr. Ramsey said in an interview. While patients were receiving the intervention, adherence averaged across all groups increased from 39% to 76%. However, once the intervention period ended, the group’s adherence regressed toward baseline (36%).

Although adherence did not associate with clinical gains in this small study, the use of digital monitoring to improve medication adherence has translated to better outcomes in other recent efforts.
 

Remote monitoring

In a quality improvement project in the United Kingdom, nurses asked difficult-to-control asthma patients if they understood how to use their corticosteroid/long-acting beta₂-agonist (LABA) inhalers and if they were adhering to treatment guidelines.

Those who answered yes to these questions were invited to a 28-day study that involved swapping their steroid/LABA inhalers for a different controller/bronchodilator (fluticasone/salmeterol) with INCA (Inhaler Compliance Assessment), a device that not only tracks adherence but also uses acoustics to gauge inhaler technique.

Among the 23 patients who participated, many had better clinical outcomes after 28 days of INCA monitoring. As Dr. Mosnaim told attendees, “what was amazing is so many of the patients that had been these difficult-to-control asthmatics who would have gone on to oral steroids or perhaps a biologic – lo and behold, you put them on a digital inhaler, and what do you see?” In two-thirds of the patients, “you see FeNo [a test that measures airway inflammation by detecting nitric oxide in exhalations] goes down. You see spirometry improve. You see the asthma control questionnaire improve. You see blood eosinophils go down.”

And in a 2020 randomized trial, Dr. Mosnaim and colleagues recruited 100 adults with uncontrolled asthma who had prescriptions for a daily inhaled corticosteroid and a short-acting beta-agonist (SABA) inhaler. Participants received Propeller sensors for their steroid and SABA inhalers. After a 2-week run-in period to calculate baseline corticosteroid adherence and SABA use for all participants, half the participants were randomly assigned to the control group, which had the app and sensor in silent mode, merely to collect data on medication use – whereas the treatment group received reminders, alerts, and monthly phone calls from providers who gave feedback on adherence and technique.

After 3 months of digital monitoring, patients didn’t use their rescue medication quite as often – as judged by a rise in the percentage of SABA-free days, compared with when they began the study. But the change in SABA-free days relative to baseline was more pronounced in the treatment group (19%) than in the control group (6%).

As seen in the other digital monitoring studies, adherence to daily corticosteroids fell with time, but the drop was milder in treated participants (2%) versus the control group (17%). So in this study, digital monitoring plus mobile app reminders and clinician feedback “prevented against fall in adherence to inhaled steroids over time,” Dr. Mosnaim said.

These results are “very encouraging” and offer “proof of concept that this type of remote monitoring could work,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., said in an interview. One limitation was that the study was too short to measure exacerbation rates. A yearlong analysis would be “really fascinating because you’d catch all the seasons of the year – all the pollen seasons, all these things that could exacerbate you. Some people’s asthma can be quite seasonal.”

More important, the clinical utility of digital sensors will depend on how physicians choose to use them. If the doctor puts out a “blanket recommendation for using it but doesn’t ask you about it or doesn’t use the data to inform your care, then I think people just lose engagement and lose excitement over it,” Dr. Ramsey said. But if the health care team “asks you about the data or looks at the data with you or shows you how valuable this can be to your care, then I think that changes things.”

Building these analyses and interactions into the clinic workflow isn’t trivial. “If you have this wealth of data coming in, how are you going to look at it? Are you going to have an individual person assigned to this role? How are you going to respond to alerts?” Dr. Anderson asked.

In addition, because some digital monitors issue alerts when a patient’s asthma is not well controlled, some providers worry about liability if “something bad were to happen if you had that data but didn’t act upon it,” he said. Yet he noted that remote data monitoring is already used routinely in other areas of medicine, such as managing diabetes and heart conditions, “and it’s not like people are getting dinged for that stuff.”

Another issue is cost. Insurance only covers digital monitors in select cases, but it’s a bit of a catch-22. Insurers “don’t want to cover it until they get the data, but you can’t get the data until insurance covers it,” said Dr. Anderson, who added that “this year we finally got CPT reimbursement codes for monitoring devices.”

On the whole, studies of digital medication monitors suggest that better outcomes require “a good partnership between the health care provider and the patient,” Dr. Pongdee said. “It wasn’t like you could just put these things on and expect them to help. You still need that personal relationship to get the optimal results. We can have all this technology, but you still can’t take the people out of it.”

Dr. Mosnaim reported receiving current research grant support from GlaxoSmithKline, Novartis, Sanofi-Regeneron, and Teva; and past research grant support from AstraZeneca, Alk-Abello, and Genentech. She is immediate past president of the AAAAI, and directs the board of directors for the American Board of Allergy and Immunology. Dr. Anderson has served as a consultant for Regeneron, GlaxoSmithKline, and AstraZeneca, and has received research support from Colorado Medicaid. Dr. McCulloch and Dr. Ramsey disclosed no relevant financial relationships. Dr. Pongdee serves as an at-large director on the American Academy of Allergy, Asthma and Immunology board of directors. He receives grant funding from GlaxoSmithKline, and the Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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

PHOENIX – Before considering oral steroids or biologic therapies, many people with difficult-to-control asthma can reduce symptoms by addressing medication adherence and inhaler technique – and digital monitoring devices can play a key role.

Often physicians “will approach a patient about a biologic if they’re not responding to standard therapy. But we need to sometimes go back to those basic building blocks, like, are you taking the standard therapy?” William C. Anderson, MD, codirector of the multidisciplinary asthma clinic at Children’s Hospital Colorado, Aurora, said in an interview.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunology, he and others presented data highlighting the diagnostic and therapeutic potential of digital monitoring devices for difficult-to-control asthma, the theme of the 2022s meeting.

The Global Initiative for Asthma (GINA) defines asthma as “difficult to control” if it remains uncontrolled despite medium- or high-dose inhaled corticosteroids with a second controller or with maintenance oral steroids, or if the asthma requires high-dose treatment to curb symptoms and exacerbations. About 17% of adult asthma patients have difficult-to-control asthma, according to the 2021 GINA report. 

However, correcting for inhaling technique and adherence cuts the 17% down to just 3.7%, Giselle Mosnaim, MD, an allergist at NorthShore University HealthSystem outside Chicago and AAAAI immediate past president, told attendees at a Feb. 25 session on digital technologies for asthma management.

The CRITIKAL study, which reviewed data from more than 5,000 asthma patients, “showed that, if you have critical errors in inhaler technique, this leads to worse asthma outcomes and increased asthma exacerbations,” Dr. Mosnaim said. Sadly, it also shows that, from 1975 to 2014, despite new devices and new technologies, “we still have poor inhaler technique.”

As for ways to measure adherence, physician judgments tend to be inaccurate, patient self-reporting has proved unreliable, and prescription refill data doesn’t indicate whether patients actually used the medications. “The ideal measure of adherence should be objective, accurate and unobtrusive to minimize impact on patient behavior and allow reliable data collection in real-world settings,” Dr. Mosnaim said. “So electronic medication monitors are the gold standard.” 
 

Tracking adherence

A closing afternoon session featured three presentations on research tracking adherence and outcomes in difficult-to-treat asthma patients – two pediatric cohorts and one across all ages. All studies used the Propeller Health sensor, a Food and Drug Administration–cleared device that attaches to the patient’s inhaler and automatically collects information on where, when, and how often they use their medication. The sensor then sends that information to a data cloud accessible to the patient and their health care professional.

Dr. Anderson’s team scoured a nationwide Propeller Health database for 8,000 patients using the digital monitors with controller therapies for asthma or chronic obstructive pulmonary disease (COPD). The study explored whether adherence differed for once-daily versus twice-daily medications, and if adherence differed based on patient age (4-60+ years).

For both asthma and COPD patients, those on once-daily regimens had higher medication adherence, compared with those who were prescribed twice-daily therapies. Plus, a greater proportion of once-daily patients met the prespecified 80% adherence threshold.

Looking across ages, medication use in the youngest group (aged 4-11 years) looked comparable with 30-somethings, “probably because parents are the ones giving the drug,” Dr. Anderson said. Mirroring patterns from other studies, adherence levels dipped in adolescents and young adults, relative to other age subsets.

Since this population-level analysis didn’t include individualized data on exacerbations or asthma control, “we can’t relate this to outcomes,” Dr. Anderson noted. But he said the data correlating medication use with adherence suggest that once-daily formulations may be the better option.

In one of the two pediatric studies, Matt McCulloch, MD, an allergy and immunology fellow working with Dr. Anderson, and colleagues reviewed charts of 40 children who received care at the Colorado Children’s multidisciplinary asthma clinic between 2018 and 2021. Half of these patients used Propeller Health sensors with their daily inhaled controller; the other patients were matched for age, ethnicity, sex, medication level, and disease control and severity – but had no electronic monitoring device.

On the whole, children who used digital monitoring for 12 months did not fare much better than matched controls on lung function (judged by forced expiratory volume) or asthma control (measured by Asthma Control Test scores).

However, within the digital monitoring group, patients who stayed on the Propeller system for 12 months did have better asthma control, fewer exacerbations, and improved asthma severity scores (measured by the Composite Asthma Severity Index), compared with when they first began digital monitoring. These children had all received care at the clinic for a while before their families opted for the electronic sensor, so “the effect wouldn’t have just been from starting in the clinic,” Dr. McCulloch said in an interview.

The gains came despite waning medication adherence. Similar to other digital monitoring studies, use of daily controller therapies in this retrospective analysis began at 50%-80% but dropped considerably during the first 4-5 months before settling into the 20%-30% range by 1 year.

Rachelle Ramsey, PhD, a pediatric research psychologist at Cincinnati Children’s Hospital Medical Center, presented data from 20 children with difficult-to-treat asthma who received 8 weeks of a digital adherence intervention during a 12-month treatment period. They analyzed three subsets – each with interventions based on how well the patients were managing daily controller therapy at baseline.

One patient with high (>80%) baseline adherence just received digital monitoring. The seven patients who began the study with intermediate (50%-80%) adherence received digital monitoring plus prescriptive text messaging. And the 12 children with poorest (<50%) baseline adherence received digital monitoring and a telehealth session in which a behavioral health specialist helped them set goals and create strategies to overcome barriers – for example, keeping the inhaler near their toothbrush in order to pair medication use with a daily habit.

“Overall, we found that matching Propeller with a behavioral intervention really improved adherence,” Dr. Ramsey said in an interview. While patients were receiving the intervention, adherence averaged across all groups increased from 39% to 76%. However, once the intervention period ended, the group’s adherence regressed toward baseline (36%).

Although adherence did not associate with clinical gains in this small study, the use of digital monitoring to improve medication adherence has translated to better outcomes in other recent efforts.
 

Remote monitoring

In a quality improvement project in the United Kingdom, nurses asked difficult-to-control asthma patients if they understood how to use their corticosteroid/long-acting beta₂-agonist (LABA) inhalers and if they were adhering to treatment guidelines.

Those who answered yes to these questions were invited to a 28-day study that involved swapping their steroid/LABA inhalers for a different controller/bronchodilator (fluticasone/salmeterol) with INCA (Inhaler Compliance Assessment), a device that not only tracks adherence but also uses acoustics to gauge inhaler technique.

Among the 23 patients who participated, many had better clinical outcomes after 28 days of INCA monitoring. As Dr. Mosnaim told attendees, “what was amazing is so many of the patients that had been these difficult-to-control asthmatics who would have gone on to oral steroids or perhaps a biologic – lo and behold, you put them on a digital inhaler, and what do you see?” In two-thirds of the patients, “you see FeNo [a test that measures airway inflammation by detecting nitric oxide in exhalations] goes down. You see spirometry improve. You see the asthma control questionnaire improve. You see blood eosinophils go down.”

And in a 2020 randomized trial, Dr. Mosnaim and colleagues recruited 100 adults with uncontrolled asthma who had prescriptions for a daily inhaled corticosteroid and a short-acting beta-agonist (SABA) inhaler. Participants received Propeller sensors for their steroid and SABA inhalers. After a 2-week run-in period to calculate baseline corticosteroid adherence and SABA use for all participants, half the participants were randomly assigned to the control group, which had the app and sensor in silent mode, merely to collect data on medication use – whereas the treatment group received reminders, alerts, and monthly phone calls from providers who gave feedback on adherence and technique.

After 3 months of digital monitoring, patients didn’t use their rescue medication quite as often – as judged by a rise in the percentage of SABA-free days, compared with when they began the study. But the change in SABA-free days relative to baseline was more pronounced in the treatment group (19%) than in the control group (6%).

As seen in the other digital monitoring studies, adherence to daily corticosteroids fell with time, but the drop was milder in treated participants (2%) versus the control group (17%). So in this study, digital monitoring plus mobile app reminders and clinician feedback “prevented against fall in adherence to inhaled steroids over time,” Dr. Mosnaim said.

These results are “very encouraging” and offer “proof of concept that this type of remote monitoring could work,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., said in an interview. One limitation was that the study was too short to measure exacerbation rates. A yearlong analysis would be “really fascinating because you’d catch all the seasons of the year – all the pollen seasons, all these things that could exacerbate you. Some people’s asthma can be quite seasonal.”

More important, the clinical utility of digital sensors will depend on how physicians choose to use them. If the doctor puts out a “blanket recommendation for using it but doesn’t ask you about it or doesn’t use the data to inform your care, then I think people just lose engagement and lose excitement over it,” Dr. Ramsey said. But if the health care team “asks you about the data or looks at the data with you or shows you how valuable this can be to your care, then I think that changes things.”

Building these analyses and interactions into the clinic workflow isn’t trivial. “If you have this wealth of data coming in, how are you going to look at it? Are you going to have an individual person assigned to this role? How are you going to respond to alerts?” Dr. Anderson asked.

In addition, because some digital monitors issue alerts when a patient’s asthma is not well controlled, some providers worry about liability if “something bad were to happen if you had that data but didn’t act upon it,” he said. Yet he noted that remote data monitoring is already used routinely in other areas of medicine, such as managing diabetes and heart conditions, “and it’s not like people are getting dinged for that stuff.”

Another issue is cost. Insurance only covers digital monitors in select cases, but it’s a bit of a catch-22. Insurers “don’t want to cover it until they get the data, but you can’t get the data until insurance covers it,” said Dr. Anderson, who added that “this year we finally got CPT reimbursement codes for monitoring devices.”

On the whole, studies of digital medication monitors suggest that better outcomes require “a good partnership between the health care provider and the patient,” Dr. Pongdee said. “It wasn’t like you could just put these things on and expect them to help. You still need that personal relationship to get the optimal results. We can have all this technology, but you still can’t take the people out of it.”

Dr. Mosnaim reported receiving current research grant support from GlaxoSmithKline, Novartis, Sanofi-Regeneron, and Teva; and past research grant support from AstraZeneca, Alk-Abello, and Genentech. She is immediate past president of the AAAAI, and directs the board of directors for the American Board of Allergy and Immunology. Dr. Anderson has served as a consultant for Regeneron, GlaxoSmithKline, and AstraZeneca, and has received research support from Colorado Medicaid. Dr. McCulloch and Dr. Ramsey disclosed no relevant financial relationships. Dr. Pongdee serves as an at-large director on the American Academy of Allergy, Asthma and Immunology board of directors. He receives grant funding from GlaxoSmithKline, and the Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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