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Could vitamin D supplementation help in long COVID?
, in a retrospective, case-matched study.
The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.
These findings, by Luigi di Filippo, MD, and colleagues, were recently presented at the European Congress of Endocrinology and published in the Journal of Clinical Endocrinology & Metabolism.
“Our data suggest that vitamin D levels should be evaluated in COVID-19 patients after hospital discharge,” wrote the researchers, from San Raffaele Hospital, Milan.
“The role of vitamin D supplementation as a preventive strategy of COVID-19 sequelae should be tested in randomized controlled trials,” they urged.
The researchers also stressed that this was a controlled study in a homogeneous population, it included multiple signs and symptoms of long COVID, and it had a longer follow-up than most previous studies (6 vs. 3 months).
“The highly controlled nature of our study helps us better understand the role of vitamin D deficiency in long COVID and establish that there is likely a link between vitamin D deficiency and long COVID,” senior author Andrea Giustina, MD, said in a press release from the ECE.
“Our study shows that COVID-19 patients with low vitamin D levels are more likely to develop long COVID, but it is not yet known whether vitamin D supplements could improve the symptoms or reduce this risk altogether,” he cautioned.
“If confirmed in large, interventional, randomized controlled trials, [our data suggest] that vitamin D supplementation could represent a possible preventive strategy in reducing the burden of COVID-19 sequelae,” Dr. Giustina and colleagues wrote.
Reasonable to test vitamin D levels, consider supplementation
Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.
“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.
“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted.
“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”
“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”
“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”
“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
Low vitamin D and risk of long COVID
Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.
Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.
Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.
Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.
Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.
Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.
Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.
The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).
Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).
Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.
Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.
Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).
In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).
And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).
The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.
The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, in a retrospective, case-matched study.
The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.
These findings, by Luigi di Filippo, MD, and colleagues, were recently presented at the European Congress of Endocrinology and published in the Journal of Clinical Endocrinology & Metabolism.
“Our data suggest that vitamin D levels should be evaluated in COVID-19 patients after hospital discharge,” wrote the researchers, from San Raffaele Hospital, Milan.
“The role of vitamin D supplementation as a preventive strategy of COVID-19 sequelae should be tested in randomized controlled trials,” they urged.
The researchers also stressed that this was a controlled study in a homogeneous population, it included multiple signs and symptoms of long COVID, and it had a longer follow-up than most previous studies (6 vs. 3 months).
“The highly controlled nature of our study helps us better understand the role of vitamin D deficiency in long COVID and establish that there is likely a link between vitamin D deficiency and long COVID,” senior author Andrea Giustina, MD, said in a press release from the ECE.
“Our study shows that COVID-19 patients with low vitamin D levels are more likely to develop long COVID, but it is not yet known whether vitamin D supplements could improve the symptoms or reduce this risk altogether,” he cautioned.
“If confirmed in large, interventional, randomized controlled trials, [our data suggest] that vitamin D supplementation could represent a possible preventive strategy in reducing the burden of COVID-19 sequelae,” Dr. Giustina and colleagues wrote.
Reasonable to test vitamin D levels, consider supplementation
Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.
“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.
“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted.
“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”
“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”
“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”
“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
Low vitamin D and risk of long COVID
Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.
Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.
Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.
Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.
Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.
Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.
Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.
The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).
Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).
Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.
Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.
Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).
In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).
And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).
The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.
The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, in a retrospective, case-matched study.
The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.
These findings, by Luigi di Filippo, MD, and colleagues, were recently presented at the European Congress of Endocrinology and published in the Journal of Clinical Endocrinology & Metabolism.
“Our data suggest that vitamin D levels should be evaluated in COVID-19 patients after hospital discharge,” wrote the researchers, from San Raffaele Hospital, Milan.
“The role of vitamin D supplementation as a preventive strategy of COVID-19 sequelae should be tested in randomized controlled trials,” they urged.
The researchers also stressed that this was a controlled study in a homogeneous population, it included multiple signs and symptoms of long COVID, and it had a longer follow-up than most previous studies (6 vs. 3 months).
“The highly controlled nature of our study helps us better understand the role of vitamin D deficiency in long COVID and establish that there is likely a link between vitamin D deficiency and long COVID,” senior author Andrea Giustina, MD, said in a press release from the ECE.
“Our study shows that COVID-19 patients with low vitamin D levels are more likely to develop long COVID, but it is not yet known whether vitamin D supplements could improve the symptoms or reduce this risk altogether,” he cautioned.
“If confirmed in large, interventional, randomized controlled trials, [our data suggest] that vitamin D supplementation could represent a possible preventive strategy in reducing the burden of COVID-19 sequelae,” Dr. Giustina and colleagues wrote.
Reasonable to test vitamin D levels, consider supplementation
Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.
“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.
“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted.
“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”
“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”
“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”
“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
Low vitamin D and risk of long COVID
Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.
Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.
Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.
Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.
Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.
Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.
Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.
The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).
Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).
Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.
Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.
Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).
In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).
And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).
The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.
The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ECE 2023
Hyperbaric oxygen may improve heart function in long COVID
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EACVI 2023
CDC: Drug-resistant ringworm reported in New York
BY ALICIA AULT
The in New York.
Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.
Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.
The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.
After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.
The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.
In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.
The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.
Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.
The authors report no relevant financial relationships.
BY ALICIA AULT
The in New York.
Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.
Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.
The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.
After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.
The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.
In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.
The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.
Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.
The authors report no relevant financial relationships.
BY ALICIA AULT
The in New York.
Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.
Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.
The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.
After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.
The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.
In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.
The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.
Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.
The authors report no relevant financial relationships.
Here’s how we can rebuild trust in vaccines
When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”
Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.
Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.
Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations.
“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
Official stumbles in part to blame
Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.
But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”
He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.
Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.
Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.
“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.
“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
Multipronged approaches
Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.
Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.
COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)
But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.
Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
Giving parents a boost in the right direction
That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.
For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.
Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.
“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.
His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.
Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”
Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.
“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”
Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.
One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.
“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.
Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.
According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.
Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.
What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.
So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”
Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”
Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.
Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.
Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations.
“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
Official stumbles in part to blame
Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.
But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”
He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.
Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.
Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.
“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.
“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
Multipronged approaches
Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.
Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.
COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)
But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.
Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
Giving parents a boost in the right direction
That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.
For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.
Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.
“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.
His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.
Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”
Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.
“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”
Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.
One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.
“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.
Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.
According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.
Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.
What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.
So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”
Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”
Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.
Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.
Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations.
“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
Official stumbles in part to blame
Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.
But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”
He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.
Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.
Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.
“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.
“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
Multipronged approaches
Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.
Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.
COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)
But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.
Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
Giving parents a boost in the right direction
That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.
For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.
Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.
“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.
His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.
Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”
Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.
“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”
Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.
One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.
“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.
Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.
According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.
Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.
What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.
So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”
Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Medical students gain momentum in effort to ban legacy admissions
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
Five ways docs may qualify for discounts on medical malpractice premiums
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
Boys may carry the weight, or overweight, of adults’ infertility
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
Clinical trials: Top priority for long COVID
The Centers for Disease Control and Prevention and the U.S. Census Bureau estimate that 6.1% of the U.S. adult population is living with long COVID, with millions more debilitated worldwide. The demand for substantial treatment is enormous, but the urgency to fund and begin the necessary range of clinical trials has not met the severity of the problem.
While trials are slowly beginning to happen, the treatment choices and trial design require crucial nuances and understanding of viral-onset illnesses, and few research groups are creating strong trials that fully reflect the complexities of this landscape.
These recommendations recognize that roughly half of long COVID patients have new-onset myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia from COVID, which must be at the forefront of how trials are designed and conducted, and are additionally based on the current hypotheses about long COVID’s pathophysiologies.
1: Drugs proposed by experts in postviral fields should be prioritized
Upward of 50 drugs for viral-onset conditions like ME/CFS, dysautonomia, AIDS, and others have been waiting for years to go to trial, but have not had the funding to do so.
Treatments proposed by experts in viral-onset illnesses (such as ME/CFS and dysautonomia) should be prioritized (PM R. 2022 Oct;14[10]:1270-91), as outside researchers are not familiar with these fields and their potential treatment options.
2: Drugs targeting a wide range of mechanisms should be trialed
Treatments that should be trialed include anticoagulants/antiplatelets for clotting and vascular functioning, immunomodulators including JAK-STAT inhibitors, COVID-specific antivirals and antivirals against reactivated herpesviruses (Valcyte, Valacyclovir, EBV vaccine).
Other options include prescription mast cell stabilizers (ketotifen, cromolyn sodium), drugs that regulate microglial activation (low-dose naltrexone, low-dose aripiprazole), anti-CGRP medications, beta-blockers, and intravenous immunoglobulin.
Others include medications that target mitochondrial dysfunction; ivabradine; pyridostigmine;, DRP1 inhibitors; supplements showing success in patient communities including lactoferrin, ubiquinone, and nattokinase; and therapies targeting glymphatic/lymphatic dysfunction, microbiome therapies, and therapeutic peptides.
3: Use appropriate long COVID subtypes
Long COVID is an umbrella term that encompasses multiple new-onset and worsened conditions and symptoms after COVID. Roughly half of long COVID patients likely meet the criteria for ME/CFS and/or dysautonomia. Others may have new-onset diabetes, major clotting events, lung damage, neurological disorders, loss of smell or taste, and other manifestations.
Patients in different categories likely have different responses to treatments. It’s critical to identify appropriate subtypes for each trial, ideally performing detailed analyses to identify the treatments that work best, and don’t, for each subtype.
4: Behavioral treatments, especially those that have harmed similar populations, should not be trialed
Behavioral treatments including exercise, graded exercise therapy (GET), and cognitive-behavioral therapy (CBT) should not be trialed, let alone prioritized, for long COVID.
In patients with postexertional malaise (PEM), one of the most common long COVID symptoms, exercise is actively harmful and causes dysfunctional metabolic patterns, cardiac preload failure, impaired systemic oxygen extraction, and more. GET and CBT have failed similar populations , and exercise is explicitly contraindicated by the World Health Organization, the British National Institute for Health and Care Excellence, the CDC, and other organizations.
Resources should instead be put toward the wide range of medications that have not yet adequately undergone clinical trials.
5: PCR and antibody tests should not be used as inclusion criteria for trial participants
Only an estimated 1%-3% of cases in the first wave of COVID were documented, and the CDC estimates that only 25% of cases through September 2021 were documented. Similarly, antibody tests are unreliable to determine past infection, as roughly a third of patients don’t seroconvert, and a similar proportion serorevert within a few months. Using polymerase chain reaction (PCR) and antibody testing to determine who should be included in clinical trials limits who is eligible to participate in research, particularly those who have been ill for longer. Additionally, the majority of those who serorevert are women, so using antibody tests for inclusion introduces a selection bias and may miss mechanisms of immune system functioning that are part of long COVID.
PCR tests also have high false-negative rates and requiring them in research excludes people with lower viral loads with long COVID, which would confound findings.
These issues with testing also lead to COVID-infected people accidentally being included in control groups, which ruins the credibility of the research findings completely.
6: Include comparator groups
There are several common diagnoses that occur in people with long COVID, including ME/CFS, postural orthostatic tachycardia syndrome, small-fiber neuropathy, mast cell activation syndrome, and Ehlers-Danlos syndrome.
Identifying people with these conditions within the trial cohort improves research across all fields, benefiting all groups, and helps clarify what types of patients benefit most from certain medications.
7: Identify the right endpoints; avoid the wrong ones
Even though our understanding of the pathophysiology of long COVID is still evolving, it’s still possible to do clinical trials by identifying strong endpoints and outcome measures.
Several tools have been designed for viral-onset conditions and should be used alongside other endpoints. Postexertional malaise and autonomic symptoms, which are some of the most common symptoms of long COVID, can be measured with the validated DSQ-PEM and COMPASS-31, respectively. Tools for cognitive dysfunction trials should capture specific and common types of impairment, like processing speed.
Endpoints should be high-impact and aim for large improvements that have clinical significance over small improvements that do not have clinical significance.
Objective tests should be incorporated where possible; some to consider include natural killer cell functioning, cerebral blood flow, T-cell functioning, levels of reactivated herpesviruses, blood lactate levels, and microclots, as testing becomes available.
Mental health outcomes shouldn’t be primary endpoints, except where a trial is targeting a specific mental health condition because of COVID (for example, premenstrual dysphoric disorder).
If mental health conditions are tracked secondarily, it’s vital not to use questionnaires that include physical symptoms like fatigue, difficulty concentrating, difficulty sleeping, or palpitations, as these artificially increase depression and anxiety scores in chronically ill respondents. Tools that include physical symptoms (Patient Health Questionnaire–9, Beck Anxiety Inventory, Beck Depression Inventory) can be replaced with scales like the PHQ-2, General Anxiety Disorder–7, Hospital Anxiety and Depression Scale, or PROMIS-29 subscales.
Because certain cytokines and other inflammatory markers may naturally decrease over time without corresponding improvement in the ME/CFS subtype, caution should be taken when using cytokines as endpoints.
8: Consider enrollment and objectives carefully
A proportion of people with long COVID will recover in the early months after infection. Ideally, clinical trials will primarily study treatments in patients who have been ill 6 months or longer, as some natural recovery will happen before that can bias studies.
But where resources are abundant, it is ideal for trials to additionally look at whether the treatments can help patients in the early months recover and prevent progression to the later stage.
9: Tracking illness duration is crucial
Research from ME/CFS shows that there may be an immune change in the first few years of the illness, where cytokines decrease without any corresponding change in symptom improvement.
Because of this and the possibility that other markers follow the same pattern, disease duration should be a core feature of all analyses and trial designs. Trial outcomes should be designed to answer the question of whether the medication helps patients at different durations of illness.
10: Prioritize patient populations less likely to recover without intervention
Some long COVID phenotypes seem less likely to recover without intervention. Trials should take care to focus on these patient populations, which include those with neurologic symptoms and those meeting ME/CFS criteria.
11: Account for the relapsing/remitting nature
Outcome measures need to be assessed in a way that can distinguish a temporary remission, which is part of the natural course of the disease, from a permanent cure.
Factors that can contribute to the relapsing/remitting nature include physical and cognitive postexertional malaise, menstrual cycle changes, and seasonal changes.
12: Trial participants should reflect the diversity of the long COVID population
Certain demographics are more likely to be affected by acute and long COVID and need to be appropriately recruited and reflected in research, including in patient engagement.
Trials must include high numbers of Hispanic/Latinx, Black, and indigenous communities, queer and transgender populations, and women. Trial materials and design need to incorporate linguistic diversity in addition to racial/ethnic diversity.
Upward of 75% of long COVID cases happen after mild acute cases; clinical researchers should ensure that nonhospitalized patients make up the bulk of trial participants.
13: Utilize meaningful engagement of patients, especially in treatment selection and study design
Meaningful patient engagement means engaging multiple patients at every step of the trial process, from treatment selection to study design to analysis to communication of the results.
Patient experiences are extremely valuable and contain information that researchers may not be familiar with, including the nature and patterns of the illness, insights into possible treatments, and barriers to documentation and care that may also impact research. Tapping into those patient experiences will make trials stronger.
Overall, the landscape of long COVID clinical trials is ripe for discovery, and researchers choosing to go down this path will be deeply appreciated by the patient community.
Hannah Davis is a long COVID patient-researcher and cofounder of the Patient-Led Research Collaborative, an organization studying the long-term effects of COVID.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention and the U.S. Census Bureau estimate that 6.1% of the U.S. adult population is living with long COVID, with millions more debilitated worldwide. The demand for substantial treatment is enormous, but the urgency to fund and begin the necessary range of clinical trials has not met the severity of the problem.
While trials are slowly beginning to happen, the treatment choices and trial design require crucial nuances and understanding of viral-onset illnesses, and few research groups are creating strong trials that fully reflect the complexities of this landscape.
These recommendations recognize that roughly half of long COVID patients have new-onset myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia from COVID, which must be at the forefront of how trials are designed and conducted, and are additionally based on the current hypotheses about long COVID’s pathophysiologies.
1: Drugs proposed by experts in postviral fields should be prioritized
Upward of 50 drugs for viral-onset conditions like ME/CFS, dysautonomia, AIDS, and others have been waiting for years to go to trial, but have not had the funding to do so.
Treatments proposed by experts in viral-onset illnesses (such as ME/CFS and dysautonomia) should be prioritized (PM R. 2022 Oct;14[10]:1270-91), as outside researchers are not familiar with these fields and their potential treatment options.
2: Drugs targeting a wide range of mechanisms should be trialed
Treatments that should be trialed include anticoagulants/antiplatelets for clotting and vascular functioning, immunomodulators including JAK-STAT inhibitors, COVID-specific antivirals and antivirals against reactivated herpesviruses (Valcyte, Valacyclovir, EBV vaccine).
Other options include prescription mast cell stabilizers (ketotifen, cromolyn sodium), drugs that regulate microglial activation (low-dose naltrexone, low-dose aripiprazole), anti-CGRP medications, beta-blockers, and intravenous immunoglobulin.
Others include medications that target mitochondrial dysfunction; ivabradine; pyridostigmine;, DRP1 inhibitors; supplements showing success in patient communities including lactoferrin, ubiquinone, and nattokinase; and therapies targeting glymphatic/lymphatic dysfunction, microbiome therapies, and therapeutic peptides.
3: Use appropriate long COVID subtypes
Long COVID is an umbrella term that encompasses multiple new-onset and worsened conditions and symptoms after COVID. Roughly half of long COVID patients likely meet the criteria for ME/CFS and/or dysautonomia. Others may have new-onset diabetes, major clotting events, lung damage, neurological disorders, loss of smell or taste, and other manifestations.
Patients in different categories likely have different responses to treatments. It’s critical to identify appropriate subtypes for each trial, ideally performing detailed analyses to identify the treatments that work best, and don’t, for each subtype.
4: Behavioral treatments, especially those that have harmed similar populations, should not be trialed
Behavioral treatments including exercise, graded exercise therapy (GET), and cognitive-behavioral therapy (CBT) should not be trialed, let alone prioritized, for long COVID.
In patients with postexertional malaise (PEM), one of the most common long COVID symptoms, exercise is actively harmful and causes dysfunctional metabolic patterns, cardiac preload failure, impaired systemic oxygen extraction, and more. GET and CBT have failed similar populations , and exercise is explicitly contraindicated by the World Health Organization, the British National Institute for Health and Care Excellence, the CDC, and other organizations.
Resources should instead be put toward the wide range of medications that have not yet adequately undergone clinical trials.
5: PCR and antibody tests should not be used as inclusion criteria for trial participants
Only an estimated 1%-3% of cases in the first wave of COVID were documented, and the CDC estimates that only 25% of cases through September 2021 were documented. Similarly, antibody tests are unreliable to determine past infection, as roughly a third of patients don’t seroconvert, and a similar proportion serorevert within a few months. Using polymerase chain reaction (PCR) and antibody testing to determine who should be included in clinical trials limits who is eligible to participate in research, particularly those who have been ill for longer. Additionally, the majority of those who serorevert are women, so using antibody tests for inclusion introduces a selection bias and may miss mechanisms of immune system functioning that are part of long COVID.
PCR tests also have high false-negative rates and requiring them in research excludes people with lower viral loads with long COVID, which would confound findings.
These issues with testing also lead to COVID-infected people accidentally being included in control groups, which ruins the credibility of the research findings completely.
6: Include comparator groups
There are several common diagnoses that occur in people with long COVID, including ME/CFS, postural orthostatic tachycardia syndrome, small-fiber neuropathy, mast cell activation syndrome, and Ehlers-Danlos syndrome.
Identifying people with these conditions within the trial cohort improves research across all fields, benefiting all groups, and helps clarify what types of patients benefit most from certain medications.
7: Identify the right endpoints; avoid the wrong ones
Even though our understanding of the pathophysiology of long COVID is still evolving, it’s still possible to do clinical trials by identifying strong endpoints and outcome measures.
Several tools have been designed for viral-onset conditions and should be used alongside other endpoints. Postexertional malaise and autonomic symptoms, which are some of the most common symptoms of long COVID, can be measured with the validated DSQ-PEM and COMPASS-31, respectively. Tools for cognitive dysfunction trials should capture specific and common types of impairment, like processing speed.
Endpoints should be high-impact and aim for large improvements that have clinical significance over small improvements that do not have clinical significance.
Objective tests should be incorporated where possible; some to consider include natural killer cell functioning, cerebral blood flow, T-cell functioning, levels of reactivated herpesviruses, blood lactate levels, and microclots, as testing becomes available.
Mental health outcomes shouldn’t be primary endpoints, except where a trial is targeting a specific mental health condition because of COVID (for example, premenstrual dysphoric disorder).
If mental health conditions are tracked secondarily, it’s vital not to use questionnaires that include physical symptoms like fatigue, difficulty concentrating, difficulty sleeping, or palpitations, as these artificially increase depression and anxiety scores in chronically ill respondents. Tools that include physical symptoms (Patient Health Questionnaire–9, Beck Anxiety Inventory, Beck Depression Inventory) can be replaced with scales like the PHQ-2, General Anxiety Disorder–7, Hospital Anxiety and Depression Scale, or PROMIS-29 subscales.
Because certain cytokines and other inflammatory markers may naturally decrease over time without corresponding improvement in the ME/CFS subtype, caution should be taken when using cytokines as endpoints.
8: Consider enrollment and objectives carefully
A proportion of people with long COVID will recover in the early months after infection. Ideally, clinical trials will primarily study treatments in patients who have been ill 6 months or longer, as some natural recovery will happen before that can bias studies.
But where resources are abundant, it is ideal for trials to additionally look at whether the treatments can help patients in the early months recover and prevent progression to the later stage.
9: Tracking illness duration is crucial
Research from ME/CFS shows that there may be an immune change in the first few years of the illness, where cytokines decrease without any corresponding change in symptom improvement.
Because of this and the possibility that other markers follow the same pattern, disease duration should be a core feature of all analyses and trial designs. Trial outcomes should be designed to answer the question of whether the medication helps patients at different durations of illness.
10: Prioritize patient populations less likely to recover without intervention
Some long COVID phenotypes seem less likely to recover without intervention. Trials should take care to focus on these patient populations, which include those with neurologic symptoms and those meeting ME/CFS criteria.
11: Account for the relapsing/remitting nature
Outcome measures need to be assessed in a way that can distinguish a temporary remission, which is part of the natural course of the disease, from a permanent cure.
Factors that can contribute to the relapsing/remitting nature include physical and cognitive postexertional malaise, menstrual cycle changes, and seasonal changes.
12: Trial participants should reflect the diversity of the long COVID population
Certain demographics are more likely to be affected by acute and long COVID and need to be appropriately recruited and reflected in research, including in patient engagement.
Trials must include high numbers of Hispanic/Latinx, Black, and indigenous communities, queer and transgender populations, and women. Trial materials and design need to incorporate linguistic diversity in addition to racial/ethnic diversity.
Upward of 75% of long COVID cases happen after mild acute cases; clinical researchers should ensure that nonhospitalized patients make up the bulk of trial participants.
13: Utilize meaningful engagement of patients, especially in treatment selection and study design
Meaningful patient engagement means engaging multiple patients at every step of the trial process, from treatment selection to study design to analysis to communication of the results.
Patient experiences are extremely valuable and contain information that researchers may not be familiar with, including the nature and patterns of the illness, insights into possible treatments, and barriers to documentation and care that may also impact research. Tapping into those patient experiences will make trials stronger.
Overall, the landscape of long COVID clinical trials is ripe for discovery, and researchers choosing to go down this path will be deeply appreciated by the patient community.
Hannah Davis is a long COVID patient-researcher and cofounder of the Patient-Led Research Collaborative, an organization studying the long-term effects of COVID.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention and the U.S. Census Bureau estimate that 6.1% of the U.S. adult population is living with long COVID, with millions more debilitated worldwide. The demand for substantial treatment is enormous, but the urgency to fund and begin the necessary range of clinical trials has not met the severity of the problem.
While trials are slowly beginning to happen, the treatment choices and trial design require crucial nuances and understanding of viral-onset illnesses, and few research groups are creating strong trials that fully reflect the complexities of this landscape.
These recommendations recognize that roughly half of long COVID patients have new-onset myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia from COVID, which must be at the forefront of how trials are designed and conducted, and are additionally based on the current hypotheses about long COVID’s pathophysiologies.
1: Drugs proposed by experts in postviral fields should be prioritized
Upward of 50 drugs for viral-onset conditions like ME/CFS, dysautonomia, AIDS, and others have been waiting for years to go to trial, but have not had the funding to do so.
Treatments proposed by experts in viral-onset illnesses (such as ME/CFS and dysautonomia) should be prioritized (PM R. 2022 Oct;14[10]:1270-91), as outside researchers are not familiar with these fields and their potential treatment options.
2: Drugs targeting a wide range of mechanisms should be trialed
Treatments that should be trialed include anticoagulants/antiplatelets for clotting and vascular functioning, immunomodulators including JAK-STAT inhibitors, COVID-specific antivirals and antivirals against reactivated herpesviruses (Valcyte, Valacyclovir, EBV vaccine).
Other options include prescription mast cell stabilizers (ketotifen, cromolyn sodium), drugs that regulate microglial activation (low-dose naltrexone, low-dose aripiprazole), anti-CGRP medications, beta-blockers, and intravenous immunoglobulin.
Others include medications that target mitochondrial dysfunction; ivabradine; pyridostigmine;, DRP1 inhibitors; supplements showing success in patient communities including lactoferrin, ubiquinone, and nattokinase; and therapies targeting glymphatic/lymphatic dysfunction, microbiome therapies, and therapeutic peptides.
3: Use appropriate long COVID subtypes
Long COVID is an umbrella term that encompasses multiple new-onset and worsened conditions and symptoms after COVID. Roughly half of long COVID patients likely meet the criteria for ME/CFS and/or dysautonomia. Others may have new-onset diabetes, major clotting events, lung damage, neurological disorders, loss of smell or taste, and other manifestations.
Patients in different categories likely have different responses to treatments. It’s critical to identify appropriate subtypes for each trial, ideally performing detailed analyses to identify the treatments that work best, and don’t, for each subtype.
4: Behavioral treatments, especially those that have harmed similar populations, should not be trialed
Behavioral treatments including exercise, graded exercise therapy (GET), and cognitive-behavioral therapy (CBT) should not be trialed, let alone prioritized, for long COVID.
In patients with postexertional malaise (PEM), one of the most common long COVID symptoms, exercise is actively harmful and causes dysfunctional metabolic patterns, cardiac preload failure, impaired systemic oxygen extraction, and more. GET and CBT have failed similar populations , and exercise is explicitly contraindicated by the World Health Organization, the British National Institute for Health and Care Excellence, the CDC, and other organizations.
Resources should instead be put toward the wide range of medications that have not yet adequately undergone clinical trials.
5: PCR and antibody tests should not be used as inclusion criteria for trial participants
Only an estimated 1%-3% of cases in the first wave of COVID were documented, and the CDC estimates that only 25% of cases through September 2021 were documented. Similarly, antibody tests are unreliable to determine past infection, as roughly a third of patients don’t seroconvert, and a similar proportion serorevert within a few months. Using polymerase chain reaction (PCR) and antibody testing to determine who should be included in clinical trials limits who is eligible to participate in research, particularly those who have been ill for longer. Additionally, the majority of those who serorevert are women, so using antibody tests for inclusion introduces a selection bias and may miss mechanisms of immune system functioning that are part of long COVID.
PCR tests also have high false-negative rates and requiring them in research excludes people with lower viral loads with long COVID, which would confound findings.
These issues with testing also lead to COVID-infected people accidentally being included in control groups, which ruins the credibility of the research findings completely.
6: Include comparator groups
There are several common diagnoses that occur in people with long COVID, including ME/CFS, postural orthostatic tachycardia syndrome, small-fiber neuropathy, mast cell activation syndrome, and Ehlers-Danlos syndrome.
Identifying people with these conditions within the trial cohort improves research across all fields, benefiting all groups, and helps clarify what types of patients benefit most from certain medications.
7: Identify the right endpoints; avoid the wrong ones
Even though our understanding of the pathophysiology of long COVID is still evolving, it’s still possible to do clinical trials by identifying strong endpoints and outcome measures.
Several tools have been designed for viral-onset conditions and should be used alongside other endpoints. Postexertional malaise and autonomic symptoms, which are some of the most common symptoms of long COVID, can be measured with the validated DSQ-PEM and COMPASS-31, respectively. Tools for cognitive dysfunction trials should capture specific and common types of impairment, like processing speed.
Endpoints should be high-impact and aim for large improvements that have clinical significance over small improvements that do not have clinical significance.
Objective tests should be incorporated where possible; some to consider include natural killer cell functioning, cerebral blood flow, T-cell functioning, levels of reactivated herpesviruses, blood lactate levels, and microclots, as testing becomes available.
Mental health outcomes shouldn’t be primary endpoints, except where a trial is targeting a specific mental health condition because of COVID (for example, premenstrual dysphoric disorder).
If mental health conditions are tracked secondarily, it’s vital not to use questionnaires that include physical symptoms like fatigue, difficulty concentrating, difficulty sleeping, or palpitations, as these artificially increase depression and anxiety scores in chronically ill respondents. Tools that include physical symptoms (Patient Health Questionnaire–9, Beck Anxiety Inventory, Beck Depression Inventory) can be replaced with scales like the PHQ-2, General Anxiety Disorder–7, Hospital Anxiety and Depression Scale, or PROMIS-29 subscales.
Because certain cytokines and other inflammatory markers may naturally decrease over time without corresponding improvement in the ME/CFS subtype, caution should be taken when using cytokines as endpoints.
8: Consider enrollment and objectives carefully
A proportion of people with long COVID will recover in the early months after infection. Ideally, clinical trials will primarily study treatments in patients who have been ill 6 months or longer, as some natural recovery will happen before that can bias studies.
But where resources are abundant, it is ideal for trials to additionally look at whether the treatments can help patients in the early months recover and prevent progression to the later stage.
9: Tracking illness duration is crucial
Research from ME/CFS shows that there may be an immune change in the first few years of the illness, where cytokines decrease without any corresponding change in symptom improvement.
Because of this and the possibility that other markers follow the same pattern, disease duration should be a core feature of all analyses and trial designs. Trial outcomes should be designed to answer the question of whether the medication helps patients at different durations of illness.
10: Prioritize patient populations less likely to recover without intervention
Some long COVID phenotypes seem less likely to recover without intervention. Trials should take care to focus on these patient populations, which include those with neurologic symptoms and those meeting ME/CFS criteria.
11: Account for the relapsing/remitting nature
Outcome measures need to be assessed in a way that can distinguish a temporary remission, which is part of the natural course of the disease, from a permanent cure.
Factors that can contribute to the relapsing/remitting nature include physical and cognitive postexertional malaise, menstrual cycle changes, and seasonal changes.
12: Trial participants should reflect the diversity of the long COVID population
Certain demographics are more likely to be affected by acute and long COVID and need to be appropriately recruited and reflected in research, including in patient engagement.
Trials must include high numbers of Hispanic/Latinx, Black, and indigenous communities, queer and transgender populations, and women. Trial materials and design need to incorporate linguistic diversity in addition to racial/ethnic diversity.
Upward of 75% of long COVID cases happen after mild acute cases; clinical researchers should ensure that nonhospitalized patients make up the bulk of trial participants.
13: Utilize meaningful engagement of patients, especially in treatment selection and study design
Meaningful patient engagement means engaging multiple patients at every step of the trial process, from treatment selection to study design to analysis to communication of the results.
Patient experiences are extremely valuable and contain information that researchers may not be familiar with, including the nature and patterns of the illness, insights into possible treatments, and barriers to documentation and care that may also impact research. Tapping into those patient experiences will make trials stronger.
Overall, the landscape of long COVID clinical trials is ripe for discovery, and researchers choosing to go down this path will be deeply appreciated by the patient community.
Hannah Davis is a long COVID patient-researcher and cofounder of the Patient-Led Research Collaborative, an organization studying the long-term effects of COVID.
A version of this article first appeared on Medscape.com.
Study of hospitalizations in Canada quantifies benefit of COVID-19 vaccine to reduce death, ICU admissions
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.
H. pylori eradication therapy curbs risk for stomach cancer
People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.
The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.
The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.
Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”
The study was published online in Gastroenterology.
Top risk factor
About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.
The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.
Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.
It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.
“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.
When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).
“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”
The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.
At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).
This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.
In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.
“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
Strong data, jury out on universal screening
For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.
The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.
“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.
“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.
Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.
“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.
The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.
The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.
The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.
Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”
The study was published online in Gastroenterology.
Top risk factor
About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.
The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.
Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.
It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.
“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.
When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).
“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”
The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.
At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).
This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.
In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.
“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
Strong data, jury out on universal screening
For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.
The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.
“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.
“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.
Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.
“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.
The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.
The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.
The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.
Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”
The study was published online in Gastroenterology.
Top risk factor
About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.
The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.
Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.
It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.
“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.
When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).
“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”
The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.
At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).
This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.
In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.
“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
Strong data, jury out on universal screening
For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.
The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.
“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.
“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.
Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.
“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.
The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM GASTROENTEROLOGY