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Update: U.S. regulators question AstraZeneca vaccine trial data

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Changed
Thu, 08/26/2021 - 15:49

Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

 

 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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

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Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

 

 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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

Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

 

 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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

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Reuters content

Abdominal aortic calcification may further raise known fracture risk

Article Type
Changed
Tue, 03/23/2021 - 08:10

 

A new study has found that older men with high levels of abdominal aortic calcification (AAC) and a prevalent vertebral fracture – both of which can be assessed via lateral spine radiographs – are at increased risk of hip, clinical vertebral, and major osteoporotic fractures.

Dr. Thomas M. Link

“The results of this study and others suggest that it may be appropriate to expand lateral spine imaging to include those with a significant pre-test probability of higher AAC being present,” wrote John T. Schousboe, MD, of the Park Nicollet Clinic and HealthPartners Institute in Bloomington, Minn. The study was published in the Journal of Bone and Mineral Research.

To determine the impact of prevalent vertebral fractures and AAC on fracture risk, the researchers assessed the lateral spine radiographs of 5,365 men who were enrolled in the Osteoporotic Fractures in Men (MrOS) study. All participants were 65 years or older, community dwelling, able to walk without assistance, and without bilateral hip arthroplasties. They split patients’ 24-point AAC (ACC-24) scores at the baseline visit into four levels: 0-1, 2-4, 5-8, and greater than 9. Self-reports of fractures were solicited from the cohort every 4 months.

Of all participants, 7.6% (n = 407) had a prevalent vertebral fracture at baseline. They were, on average, 1.5 years older than participants without a fracture; they were also more likely to be white and to have a prior nonspine fracture, along with having a lower femoral neck BMD (0.718 g/cm2, compared with 0.787 g/cm2; P < .001). In addition, significantly more men with a prevalent vertebral fracture had an AAC score greater than 9 (27% vs. 21.2%).



After an average follow-up period of 12.4 years (standard deviation, 5.2), 634 men had a major osteoporotic fracture, 283 had a hip fracture, 206 had a clinical vertebral fracture, and 2,626 died without having any of the three. After adjustment for risk factors such as age, prior nonspine fracture, and prevalent vertebral fracture, men with higher AAC-24 scores had a higher risk of major osteoporotic fracture, compared with men who had scores of 0-1: a hazard ratio of 1.38 (95% confidence interval, 1.10-1.73; P < .001) for scores 2-4, a HR of 1.45 (95% CI, 1.14-1.84; P < .001) for scores 5-8, and a HR of 1.65 (95% CI, 1.29-2.10; P < .001) for scores greater than 9.

Similar findings were reported regarding risk of hip fractures: a HR of 1.54 (95% CI, 1.07-2.20; P < .001) for men with AAC-24 scores 2-4, a HR of 1.40 (95% CI, 0.96-2.06; P < .001) for scores 5-8, and a HR of 2.17 (95% CI, 1.50-3.13; P < .001) for scores greater than 9. AAC-24 score severity was not associated with a higher risk of clinical vertebral fractures.

After adjustment for risk factors and AAC-24 score, men with prevalent vertebral fractures had an increased risk of all three fracture outcomes, compared with men without any fractures at baseline: a HR of 1.56 (95% CI, 1.12-2.16; P < .001) for hip fracture, a HR of 1.85 (95% CI, 1.48-2.31; P < .001) for major osteoporotic fracture, and a HR of 2.76 (95% CI, 1.94-3.91; P < .001) for clinical vertebral fracture.

Adjusting for competing mortality produced similar results: men with higher levels of AAC had increased risk of major osteoporotic fracture and hip fracture, although AAC-24 score was not associated with higher risk of clinical vertebral fractures. Prevalent vertebral fractures were also still associated with higher risk of hip (subdistribution HR, 1.42; 95% CI, 1.01-2.00; P = .004), major osteoporotic fracture (SHR, 1.71; 95% CI, 1.36-2.14; P < .001), and clinical vertebral fracture (SHR, 2.46; 95% CI, 1.72-3.52; P < .001).

 

 

Fracture risk assessment proves to be “a nice proof of concept”

“It’s well known that prevalent fractures predict future fractures,” said Thomas M. Link, MD, PhD, chief of the musculoskeletal imaging section in the department of radiology and biomedical imaging at the University of California, San Francisco, in an interview. “The new finding is that aortic calcifications combined with prevalent fractures perform better in predicting major osteoporotic fractures. Traditionally on radiographs, we note that patients who have more calcifications in vessels have less density or calcium in the bone, so this is a nice proof of concept.”

“While the study shows excellent reproducibility, it is not clear how the AAC-24 score was validated,” he added. “Theoretically, abdominal CT could be used for this.”

Along with validation of the AAC-24 score on lateral spine radiographs, he expressed a desire that future research would be “clearer regarding how this would potentially impact patient management. Prevalent fractures already are an indication to treat patients with osteoporosis-specific drugs. How would the results of this study impact management beyond that?”



The authors acknowledged their study’s other potential limitations, including limits in their ability to estimate absolute and relative hip fracture risk in men with low AAC scores but a prevalent vertebral fracture. In addition, they noted that their cohort was “mostly white, healthy, community-dwelling older men” and therefore may not be generalizable to other populations.

The study was supported by the National Institutes of Health, including grants from the National Institute on Aging, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Advancing Translational Sciences, and the NIH Roadmap for Medical Research. One author reported being supported by a National Heart Foundation of Australia Future Leader Fellowship. The others disclosed no potential conflicts of interest.

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A new study has found that older men with high levels of abdominal aortic calcification (AAC) and a prevalent vertebral fracture – both of which can be assessed via lateral spine radiographs – are at increased risk of hip, clinical vertebral, and major osteoporotic fractures.

Dr. Thomas M. Link

“The results of this study and others suggest that it may be appropriate to expand lateral spine imaging to include those with a significant pre-test probability of higher AAC being present,” wrote John T. Schousboe, MD, of the Park Nicollet Clinic and HealthPartners Institute in Bloomington, Minn. The study was published in the Journal of Bone and Mineral Research.

To determine the impact of prevalent vertebral fractures and AAC on fracture risk, the researchers assessed the lateral spine radiographs of 5,365 men who were enrolled in the Osteoporotic Fractures in Men (MrOS) study. All participants were 65 years or older, community dwelling, able to walk without assistance, and without bilateral hip arthroplasties. They split patients’ 24-point AAC (ACC-24) scores at the baseline visit into four levels: 0-1, 2-4, 5-8, and greater than 9. Self-reports of fractures were solicited from the cohort every 4 months.

Of all participants, 7.6% (n = 407) had a prevalent vertebral fracture at baseline. They were, on average, 1.5 years older than participants without a fracture; they were also more likely to be white and to have a prior nonspine fracture, along with having a lower femoral neck BMD (0.718 g/cm2, compared with 0.787 g/cm2; P < .001). In addition, significantly more men with a prevalent vertebral fracture had an AAC score greater than 9 (27% vs. 21.2%).



After an average follow-up period of 12.4 years (standard deviation, 5.2), 634 men had a major osteoporotic fracture, 283 had a hip fracture, 206 had a clinical vertebral fracture, and 2,626 died without having any of the three. After adjustment for risk factors such as age, prior nonspine fracture, and prevalent vertebral fracture, men with higher AAC-24 scores had a higher risk of major osteoporotic fracture, compared with men who had scores of 0-1: a hazard ratio of 1.38 (95% confidence interval, 1.10-1.73; P < .001) for scores 2-4, a HR of 1.45 (95% CI, 1.14-1.84; P < .001) for scores 5-8, and a HR of 1.65 (95% CI, 1.29-2.10; P < .001) for scores greater than 9.

Similar findings were reported regarding risk of hip fractures: a HR of 1.54 (95% CI, 1.07-2.20; P < .001) for men with AAC-24 scores 2-4, a HR of 1.40 (95% CI, 0.96-2.06; P < .001) for scores 5-8, and a HR of 2.17 (95% CI, 1.50-3.13; P < .001) for scores greater than 9. AAC-24 score severity was not associated with a higher risk of clinical vertebral fractures.

After adjustment for risk factors and AAC-24 score, men with prevalent vertebral fractures had an increased risk of all three fracture outcomes, compared with men without any fractures at baseline: a HR of 1.56 (95% CI, 1.12-2.16; P < .001) for hip fracture, a HR of 1.85 (95% CI, 1.48-2.31; P < .001) for major osteoporotic fracture, and a HR of 2.76 (95% CI, 1.94-3.91; P < .001) for clinical vertebral fracture.

Adjusting for competing mortality produced similar results: men with higher levels of AAC had increased risk of major osteoporotic fracture and hip fracture, although AAC-24 score was not associated with higher risk of clinical vertebral fractures. Prevalent vertebral fractures were also still associated with higher risk of hip (subdistribution HR, 1.42; 95% CI, 1.01-2.00; P = .004), major osteoporotic fracture (SHR, 1.71; 95% CI, 1.36-2.14; P < .001), and clinical vertebral fracture (SHR, 2.46; 95% CI, 1.72-3.52; P < .001).

 

 

Fracture risk assessment proves to be “a nice proof of concept”

“It’s well known that prevalent fractures predict future fractures,” said Thomas M. Link, MD, PhD, chief of the musculoskeletal imaging section in the department of radiology and biomedical imaging at the University of California, San Francisco, in an interview. “The new finding is that aortic calcifications combined with prevalent fractures perform better in predicting major osteoporotic fractures. Traditionally on radiographs, we note that patients who have more calcifications in vessels have less density or calcium in the bone, so this is a nice proof of concept.”

“While the study shows excellent reproducibility, it is not clear how the AAC-24 score was validated,” he added. “Theoretically, abdominal CT could be used for this.”

Along with validation of the AAC-24 score on lateral spine radiographs, he expressed a desire that future research would be “clearer regarding how this would potentially impact patient management. Prevalent fractures already are an indication to treat patients with osteoporosis-specific drugs. How would the results of this study impact management beyond that?”



The authors acknowledged their study’s other potential limitations, including limits in their ability to estimate absolute and relative hip fracture risk in men with low AAC scores but a prevalent vertebral fracture. In addition, they noted that their cohort was “mostly white, healthy, community-dwelling older men” and therefore may not be generalizable to other populations.

The study was supported by the National Institutes of Health, including grants from the National Institute on Aging, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Advancing Translational Sciences, and the NIH Roadmap for Medical Research. One author reported being supported by a National Heart Foundation of Australia Future Leader Fellowship. The others disclosed no potential conflicts of interest.

 

A new study has found that older men with high levels of abdominal aortic calcification (AAC) and a prevalent vertebral fracture – both of which can be assessed via lateral spine radiographs – are at increased risk of hip, clinical vertebral, and major osteoporotic fractures.

Dr. Thomas M. Link

“The results of this study and others suggest that it may be appropriate to expand lateral spine imaging to include those with a significant pre-test probability of higher AAC being present,” wrote John T. Schousboe, MD, of the Park Nicollet Clinic and HealthPartners Institute in Bloomington, Minn. The study was published in the Journal of Bone and Mineral Research.

To determine the impact of prevalent vertebral fractures and AAC on fracture risk, the researchers assessed the lateral spine radiographs of 5,365 men who were enrolled in the Osteoporotic Fractures in Men (MrOS) study. All participants were 65 years or older, community dwelling, able to walk without assistance, and without bilateral hip arthroplasties. They split patients’ 24-point AAC (ACC-24) scores at the baseline visit into four levels: 0-1, 2-4, 5-8, and greater than 9. Self-reports of fractures were solicited from the cohort every 4 months.

Of all participants, 7.6% (n = 407) had a prevalent vertebral fracture at baseline. They were, on average, 1.5 years older than participants without a fracture; they were also more likely to be white and to have a prior nonspine fracture, along with having a lower femoral neck BMD (0.718 g/cm2, compared with 0.787 g/cm2; P < .001). In addition, significantly more men with a prevalent vertebral fracture had an AAC score greater than 9 (27% vs. 21.2%).



After an average follow-up period of 12.4 years (standard deviation, 5.2), 634 men had a major osteoporotic fracture, 283 had a hip fracture, 206 had a clinical vertebral fracture, and 2,626 died without having any of the three. After adjustment for risk factors such as age, prior nonspine fracture, and prevalent vertebral fracture, men with higher AAC-24 scores had a higher risk of major osteoporotic fracture, compared with men who had scores of 0-1: a hazard ratio of 1.38 (95% confidence interval, 1.10-1.73; P < .001) for scores 2-4, a HR of 1.45 (95% CI, 1.14-1.84; P < .001) for scores 5-8, and a HR of 1.65 (95% CI, 1.29-2.10; P < .001) for scores greater than 9.

Similar findings were reported regarding risk of hip fractures: a HR of 1.54 (95% CI, 1.07-2.20; P < .001) for men with AAC-24 scores 2-4, a HR of 1.40 (95% CI, 0.96-2.06; P < .001) for scores 5-8, and a HR of 2.17 (95% CI, 1.50-3.13; P < .001) for scores greater than 9. AAC-24 score severity was not associated with a higher risk of clinical vertebral fractures.

After adjustment for risk factors and AAC-24 score, men with prevalent vertebral fractures had an increased risk of all three fracture outcomes, compared with men without any fractures at baseline: a HR of 1.56 (95% CI, 1.12-2.16; P < .001) for hip fracture, a HR of 1.85 (95% CI, 1.48-2.31; P < .001) for major osteoporotic fracture, and a HR of 2.76 (95% CI, 1.94-3.91; P < .001) for clinical vertebral fracture.

Adjusting for competing mortality produced similar results: men with higher levels of AAC had increased risk of major osteoporotic fracture and hip fracture, although AAC-24 score was not associated with higher risk of clinical vertebral fractures. Prevalent vertebral fractures were also still associated with higher risk of hip (subdistribution HR, 1.42; 95% CI, 1.01-2.00; P = .004), major osteoporotic fracture (SHR, 1.71; 95% CI, 1.36-2.14; P < .001), and clinical vertebral fracture (SHR, 2.46; 95% CI, 1.72-3.52; P < .001).

 

 

Fracture risk assessment proves to be “a nice proof of concept”

“It’s well known that prevalent fractures predict future fractures,” said Thomas M. Link, MD, PhD, chief of the musculoskeletal imaging section in the department of radiology and biomedical imaging at the University of California, San Francisco, in an interview. “The new finding is that aortic calcifications combined with prevalent fractures perform better in predicting major osteoporotic fractures. Traditionally on radiographs, we note that patients who have more calcifications in vessels have less density or calcium in the bone, so this is a nice proof of concept.”

“While the study shows excellent reproducibility, it is not clear how the AAC-24 score was validated,” he added. “Theoretically, abdominal CT could be used for this.”

Along with validation of the AAC-24 score on lateral spine radiographs, he expressed a desire that future research would be “clearer regarding how this would potentially impact patient management. Prevalent fractures already are an indication to treat patients with osteoporosis-specific drugs. How would the results of this study impact management beyond that?”



The authors acknowledged their study’s other potential limitations, including limits in their ability to estimate absolute and relative hip fracture risk in men with low AAC scores but a prevalent vertebral fracture. In addition, they noted that their cohort was “mostly white, healthy, community-dwelling older men” and therefore may not be generalizable to other populations.

The study was supported by the National Institutes of Health, including grants from the National Institute on Aging, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Advancing Translational Sciences, and the NIH Roadmap for Medical Research. One author reported being supported by a National Heart Foundation of Australia Future Leader Fellowship. The others disclosed no potential conflicts of interest.

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FROM THE JOURNAL OF BONE AND MINERAL RESEARCH

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How to talk to patients reluctant to get a COVID-19 vaccine

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Changed
Thu, 08/26/2021 - 15:49

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient’s comments stopped him cold. The patient, a middle-aged man with several comorbidities had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn’t be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

Dr. Mitchell A. Kaminski

Dr. Kaminski countered with medical facts, including that the very rare side effects hadn’t killed anyone in the United States but COVID was killing thousands of people every day. “Well then, I’ll just risk getting COVID,” Dr. Kaminski recalled the patient saying. Conversation over.

That experience caused Dr. Kaminski, who is program director for population health at Thomas Jefferson University, Philadelphia, to rethink the way he talks to patients who are uncertain or skeptical about getting a COVID-19 vaccine. Now, if he saw that patient who seemed fearful of dying from a vaccination, Dr. Kaminski said he would be more curious.

Instead of outright contradicting the beliefs of a patient who is reluctant to get vaccinated, Dr. Kaminski now gently asks about the reasons for their discomfort and offers information about the vaccines. But mostly, he listens.

©Sean Warren/iStockphoto.com

Conversations between physicians and patients about the risks that come with getting a COVID-19 vaccine are becoming more common in general as eligibility for immunizations expands. Physicians are using a variety of methods to communicate about the safety and importance of getting vaccinated that they think will lead to more of their patients getting a COVID-19 vaccine.

About 80% of Americans say that they are most likely to turn to doctors, nurses and other health professionals for help in deciding whether to get the COVID vaccine, according to research by the Kaiser Family Foundation.
 

Getting beyond the distrust

While patients often feel a strong connection with their health providers, distrust in the medical establishment still exists, especially among some populations. The Kaiser Family Foundation reported that a third of Black respondents are taking a “wait-and-see” approach, while 23% said they will get it only if it’s required – or not at all.

Dr. Krys Foster

Distrust persists from historical racist events in medicine, such as the infamous Tuskegee experiments in which treatment was withheld from Black men with syphilis. But physicians shouldn’t assume that all Black patients have the same reasons for vaccine hesitancy, said Krys Foster, MD, MPH, a family physician at Thomas Jefferson University.

“In my experience caring for patients who are uncertain or have concerns about receiving the vaccine, I’ve learned that many are just seeking more information, or even my approval to say that it is safe to proceed given their medical history,” she said.

Sources such as the COVID Racial Data Tracker have found that Black Americans have a higher COVID death rate than other racial or ethnic groups, making vaccination even more vital. Yet fear of the vaccine could be triggered by misinformation that can be found in various places online, Dr. Foster said.

To encourage people to get vaccinated and dispel false information, Dr. Foster takes time to discuss how safe it is to get a COVID-19 vaccine and the vaccines’ side effects, then quickly pivots to discussing how to get vaccinated.

It can be difficult for some people to find appointments or access testing sites. The failure to get the vaccine shouldn’t automatically be attributed to “hesitancy,” she said. “The onus is on the medical community to help fix the health injustices inflicted on communities of color by providing equitable information and access and stop placing blame on them for having the ‘wrong’ vaccine attitude.”
 

 

 

Give your testimonial

Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., said he has always had a higher-than-average number of patients who refused or delayed their children’s vaccines. He does not kick them out of his practice but politely continues to educate them about the vaccines.

Dr. Jamie Loehr

When patients ask Dr. Loehr if he trusts the vaccine, he responds with confidence: “I not only believe in it, I got it and I recommend it to anyone who can possibly get it.”

He was surprised recently when a mother who has expressed reluctance to vaccinate her young children came for a checkup and told him she had already received a COVID vaccine. “She made the decision on her own that this was important enough that she wanted to get it,” he said.
 

Health care worker hesitancy

Some health care workers’ unease about being at the front of the line for vaccines may be another source of vaccine hesitancy among members of the general population that physicians need to address. In a survey of almost 3,500 health care workers conducted in October and November 2020 and published in January 2021 in Vaccines, only about a third (36%) said they would get the vaccine as soon as it became available. By mid- to late-February, 54% of health care workers reported having been vaccinated and another 10% planned to get the vaccine as soon as possible, according to the Kaiser Family Foundation COVID-19 Vaccine Monitor.

Dr. Eileen Barrett

Resolving doubts about the vaccines requires a thoughtful approach toward health care colleagues, said Eileen Barrett, MD, MPH, an internist and hospitalist who was a coauthor of the Vaccines paper and who serves on the editorial advisory board of Internal Medicine News. “We should meet people where they are and do our best to hear their concerns, listening thoughtfully without condescension. Validate how important their role is in endorsing vaccination and also validate asking questions.”

There’s power in the strong personal testimonial of physicians and other health care workers – not just to influence patients, but as a model for fellow health professionals, as well, noted Dr. Barrett, who cares for COVID-19 patients and is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
 

‘Do it for your loved ones’

The Reagan-Udall Foundation, a nonprofit organization created by Congress to support the Food and Drug Administration, tested some messaging with focus groups. Participants responded favorably to this statement about why the vaccines were developed so quickly: “Vaccine development moved faster than normal because everyone’s making it their highest priority.”

People did not feel motivated to get the vaccine out of a sense of civic duty, said Susan Winckler, RPh, Esq, who is CEO of the foundation. But they did think the following was a good reason to get vaccinated: “By getting a vaccine, I could protect my children, my parents, and other loved ones.”

Physicians also can work with community influencers, such as faith leaders, to build confidence in vaccines. That’s part of the strategy of Roll Up Your Sleeves, a campaign spearheaded by agilon health, a company that partners with physician practices to develop value-based care for Medicare Advantage patients.

For example, Wilmington Health in North Carolina answered questions about the vaccines in Facebook Live events and created a Spanish-language video to boost vaccine confidence in the Latinx community. Additionally, PriMED Physicians in Dayton, Ohio, reached out to Black churches to provide a vaccine-awareness video and a PriMED doctor participated in a webinar sponsored by the Nigerian Women Cultural Organization to help dispel myths about COVID-19 and the vaccines.

Dr. Ben Kornitzer

“This is a way to deepen our relationship with our patients,” said Ben Kornitzer, MD, chief medical officer of agilon. “It’s helping to walk them through this door where on one side is the pandemic and social isolation and on the other side is a return to their life and loved ones.”

The messages provided by primary care physicians can be powerful and affirming, said Ms. Winckler.

“The path forward is to make a space for people to ask questions,” she continued, noting that the Reagan-Udall Foundation provides charts that show how the timeline for vaccine development was compressed without skipping any steps.

Strategies and background information on how to reinforce confidence in COVID-19 vaccines are also available on a page of the Centers for Disease Control and Prevention’s website.

None of the experts interviewed reported any relevant conflicts of interest. The Reagan-Udall Foundation has received sponsorships from Johnson & Johnson and AstraZeneca and has had a safety surveillance contract with Pfizer.

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Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient’s comments stopped him cold. The patient, a middle-aged man with several comorbidities had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn’t be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

Dr. Mitchell A. Kaminski

Dr. Kaminski countered with medical facts, including that the very rare side effects hadn’t killed anyone in the United States but COVID was killing thousands of people every day. “Well then, I’ll just risk getting COVID,” Dr. Kaminski recalled the patient saying. Conversation over.

That experience caused Dr. Kaminski, who is program director for population health at Thomas Jefferson University, Philadelphia, to rethink the way he talks to patients who are uncertain or skeptical about getting a COVID-19 vaccine. Now, if he saw that patient who seemed fearful of dying from a vaccination, Dr. Kaminski said he would be more curious.

Instead of outright contradicting the beliefs of a patient who is reluctant to get vaccinated, Dr. Kaminski now gently asks about the reasons for their discomfort and offers information about the vaccines. But mostly, he listens.

©Sean Warren/iStockphoto.com

Conversations between physicians and patients about the risks that come with getting a COVID-19 vaccine are becoming more common in general as eligibility for immunizations expands. Physicians are using a variety of methods to communicate about the safety and importance of getting vaccinated that they think will lead to more of their patients getting a COVID-19 vaccine.

About 80% of Americans say that they are most likely to turn to doctors, nurses and other health professionals for help in deciding whether to get the COVID vaccine, according to research by the Kaiser Family Foundation.
 

Getting beyond the distrust

While patients often feel a strong connection with their health providers, distrust in the medical establishment still exists, especially among some populations. The Kaiser Family Foundation reported that a third of Black respondents are taking a “wait-and-see” approach, while 23% said they will get it only if it’s required – or not at all.

Dr. Krys Foster

Distrust persists from historical racist events in medicine, such as the infamous Tuskegee experiments in which treatment was withheld from Black men with syphilis. But physicians shouldn’t assume that all Black patients have the same reasons for vaccine hesitancy, said Krys Foster, MD, MPH, a family physician at Thomas Jefferson University.

“In my experience caring for patients who are uncertain or have concerns about receiving the vaccine, I’ve learned that many are just seeking more information, or even my approval to say that it is safe to proceed given their medical history,” she said.

Sources such as the COVID Racial Data Tracker have found that Black Americans have a higher COVID death rate than other racial or ethnic groups, making vaccination even more vital. Yet fear of the vaccine could be triggered by misinformation that can be found in various places online, Dr. Foster said.

To encourage people to get vaccinated and dispel false information, Dr. Foster takes time to discuss how safe it is to get a COVID-19 vaccine and the vaccines’ side effects, then quickly pivots to discussing how to get vaccinated.

It can be difficult for some people to find appointments or access testing sites. The failure to get the vaccine shouldn’t automatically be attributed to “hesitancy,” she said. “The onus is on the medical community to help fix the health injustices inflicted on communities of color by providing equitable information and access and stop placing blame on them for having the ‘wrong’ vaccine attitude.”
 

 

 

Give your testimonial

Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., said he has always had a higher-than-average number of patients who refused or delayed their children’s vaccines. He does not kick them out of his practice but politely continues to educate them about the vaccines.

Dr. Jamie Loehr

When patients ask Dr. Loehr if he trusts the vaccine, he responds with confidence: “I not only believe in it, I got it and I recommend it to anyone who can possibly get it.”

He was surprised recently when a mother who has expressed reluctance to vaccinate her young children came for a checkup and told him she had already received a COVID vaccine. “She made the decision on her own that this was important enough that she wanted to get it,” he said.
 

Health care worker hesitancy

Some health care workers’ unease about being at the front of the line for vaccines may be another source of vaccine hesitancy among members of the general population that physicians need to address. In a survey of almost 3,500 health care workers conducted in October and November 2020 and published in January 2021 in Vaccines, only about a third (36%) said they would get the vaccine as soon as it became available. By mid- to late-February, 54% of health care workers reported having been vaccinated and another 10% planned to get the vaccine as soon as possible, according to the Kaiser Family Foundation COVID-19 Vaccine Monitor.

Dr. Eileen Barrett

Resolving doubts about the vaccines requires a thoughtful approach toward health care colleagues, said Eileen Barrett, MD, MPH, an internist and hospitalist who was a coauthor of the Vaccines paper and who serves on the editorial advisory board of Internal Medicine News. “We should meet people where they are and do our best to hear their concerns, listening thoughtfully without condescension. Validate how important their role is in endorsing vaccination and also validate asking questions.”

There’s power in the strong personal testimonial of physicians and other health care workers – not just to influence patients, but as a model for fellow health professionals, as well, noted Dr. Barrett, who cares for COVID-19 patients and is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
 

‘Do it for your loved ones’

The Reagan-Udall Foundation, a nonprofit organization created by Congress to support the Food and Drug Administration, tested some messaging with focus groups. Participants responded favorably to this statement about why the vaccines were developed so quickly: “Vaccine development moved faster than normal because everyone’s making it their highest priority.”

People did not feel motivated to get the vaccine out of a sense of civic duty, said Susan Winckler, RPh, Esq, who is CEO of the foundation. But they did think the following was a good reason to get vaccinated: “By getting a vaccine, I could protect my children, my parents, and other loved ones.”

Physicians also can work with community influencers, such as faith leaders, to build confidence in vaccines. That’s part of the strategy of Roll Up Your Sleeves, a campaign spearheaded by agilon health, a company that partners with physician practices to develop value-based care for Medicare Advantage patients.

For example, Wilmington Health in North Carolina answered questions about the vaccines in Facebook Live events and created a Spanish-language video to boost vaccine confidence in the Latinx community. Additionally, PriMED Physicians in Dayton, Ohio, reached out to Black churches to provide a vaccine-awareness video and a PriMED doctor participated in a webinar sponsored by the Nigerian Women Cultural Organization to help dispel myths about COVID-19 and the vaccines.

Dr. Ben Kornitzer

“This is a way to deepen our relationship with our patients,” said Ben Kornitzer, MD, chief medical officer of agilon. “It’s helping to walk them through this door where on one side is the pandemic and social isolation and on the other side is a return to their life and loved ones.”

The messages provided by primary care physicians can be powerful and affirming, said Ms. Winckler.

“The path forward is to make a space for people to ask questions,” she continued, noting that the Reagan-Udall Foundation provides charts that show how the timeline for vaccine development was compressed without skipping any steps.

Strategies and background information on how to reinforce confidence in COVID-19 vaccines are also available on a page of the Centers for Disease Control and Prevention’s website.

None of the experts interviewed reported any relevant conflicts of interest. The Reagan-Udall Foundation has received sponsorships from Johnson & Johnson and AstraZeneca and has had a safety surveillance contract with Pfizer.

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient’s comments stopped him cold. The patient, a middle-aged man with several comorbidities had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn’t be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

Dr. Mitchell A. Kaminski

Dr. Kaminski countered with medical facts, including that the very rare side effects hadn’t killed anyone in the United States but COVID was killing thousands of people every day. “Well then, I’ll just risk getting COVID,” Dr. Kaminski recalled the patient saying. Conversation over.

That experience caused Dr. Kaminski, who is program director for population health at Thomas Jefferson University, Philadelphia, to rethink the way he talks to patients who are uncertain or skeptical about getting a COVID-19 vaccine. Now, if he saw that patient who seemed fearful of dying from a vaccination, Dr. Kaminski said he would be more curious.

Instead of outright contradicting the beliefs of a patient who is reluctant to get vaccinated, Dr. Kaminski now gently asks about the reasons for their discomfort and offers information about the vaccines. But mostly, he listens.

©Sean Warren/iStockphoto.com

Conversations between physicians and patients about the risks that come with getting a COVID-19 vaccine are becoming more common in general as eligibility for immunizations expands. Physicians are using a variety of methods to communicate about the safety and importance of getting vaccinated that they think will lead to more of their patients getting a COVID-19 vaccine.

About 80% of Americans say that they are most likely to turn to doctors, nurses and other health professionals for help in deciding whether to get the COVID vaccine, according to research by the Kaiser Family Foundation.
 

Getting beyond the distrust

While patients often feel a strong connection with their health providers, distrust in the medical establishment still exists, especially among some populations. The Kaiser Family Foundation reported that a third of Black respondents are taking a “wait-and-see” approach, while 23% said they will get it only if it’s required – or not at all.

Dr. Krys Foster

Distrust persists from historical racist events in medicine, such as the infamous Tuskegee experiments in which treatment was withheld from Black men with syphilis. But physicians shouldn’t assume that all Black patients have the same reasons for vaccine hesitancy, said Krys Foster, MD, MPH, a family physician at Thomas Jefferson University.

“In my experience caring for patients who are uncertain or have concerns about receiving the vaccine, I’ve learned that many are just seeking more information, or even my approval to say that it is safe to proceed given their medical history,” she said.

Sources such as the COVID Racial Data Tracker have found that Black Americans have a higher COVID death rate than other racial or ethnic groups, making vaccination even more vital. Yet fear of the vaccine could be triggered by misinformation that can be found in various places online, Dr. Foster said.

To encourage people to get vaccinated and dispel false information, Dr. Foster takes time to discuss how safe it is to get a COVID-19 vaccine and the vaccines’ side effects, then quickly pivots to discussing how to get vaccinated.

It can be difficult for some people to find appointments or access testing sites. The failure to get the vaccine shouldn’t automatically be attributed to “hesitancy,” she said. “The onus is on the medical community to help fix the health injustices inflicted on communities of color by providing equitable information and access and stop placing blame on them for having the ‘wrong’ vaccine attitude.”
 

 

 

Give your testimonial

Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., said he has always had a higher-than-average number of patients who refused or delayed their children’s vaccines. He does not kick them out of his practice but politely continues to educate them about the vaccines.

Dr. Jamie Loehr

When patients ask Dr. Loehr if he trusts the vaccine, he responds with confidence: “I not only believe in it, I got it and I recommend it to anyone who can possibly get it.”

He was surprised recently when a mother who has expressed reluctance to vaccinate her young children came for a checkup and told him she had already received a COVID vaccine. “She made the decision on her own that this was important enough that she wanted to get it,” he said.
 

Health care worker hesitancy

Some health care workers’ unease about being at the front of the line for vaccines may be another source of vaccine hesitancy among members of the general population that physicians need to address. In a survey of almost 3,500 health care workers conducted in October and November 2020 and published in January 2021 in Vaccines, only about a third (36%) said they would get the vaccine as soon as it became available. By mid- to late-February, 54% of health care workers reported having been vaccinated and another 10% planned to get the vaccine as soon as possible, according to the Kaiser Family Foundation COVID-19 Vaccine Monitor.

Dr. Eileen Barrett

Resolving doubts about the vaccines requires a thoughtful approach toward health care colleagues, said Eileen Barrett, MD, MPH, an internist and hospitalist who was a coauthor of the Vaccines paper and who serves on the editorial advisory board of Internal Medicine News. “We should meet people where they are and do our best to hear their concerns, listening thoughtfully without condescension. Validate how important their role is in endorsing vaccination and also validate asking questions.”

There’s power in the strong personal testimonial of physicians and other health care workers – not just to influence patients, but as a model for fellow health professionals, as well, noted Dr. Barrett, who cares for COVID-19 patients and is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
 

‘Do it for your loved ones’

The Reagan-Udall Foundation, a nonprofit organization created by Congress to support the Food and Drug Administration, tested some messaging with focus groups. Participants responded favorably to this statement about why the vaccines were developed so quickly: “Vaccine development moved faster than normal because everyone’s making it their highest priority.”

People did not feel motivated to get the vaccine out of a sense of civic duty, said Susan Winckler, RPh, Esq, who is CEO of the foundation. But they did think the following was a good reason to get vaccinated: “By getting a vaccine, I could protect my children, my parents, and other loved ones.”

Physicians also can work with community influencers, such as faith leaders, to build confidence in vaccines. That’s part of the strategy of Roll Up Your Sleeves, a campaign spearheaded by agilon health, a company that partners with physician practices to develop value-based care for Medicare Advantage patients.

For example, Wilmington Health in North Carolina answered questions about the vaccines in Facebook Live events and created a Spanish-language video to boost vaccine confidence in the Latinx community. Additionally, PriMED Physicians in Dayton, Ohio, reached out to Black churches to provide a vaccine-awareness video and a PriMED doctor participated in a webinar sponsored by the Nigerian Women Cultural Organization to help dispel myths about COVID-19 and the vaccines.

Dr. Ben Kornitzer

“This is a way to deepen our relationship with our patients,” said Ben Kornitzer, MD, chief medical officer of agilon. “It’s helping to walk them through this door where on one side is the pandemic and social isolation and on the other side is a return to their life and loved ones.”

The messages provided by primary care physicians can be powerful and affirming, said Ms. Winckler.

“The path forward is to make a space for people to ask questions,” she continued, noting that the Reagan-Udall Foundation provides charts that show how the timeline for vaccine development was compressed without skipping any steps.

Strategies and background information on how to reinforce confidence in COVID-19 vaccines are also available on a page of the Centers for Disease Control and Prevention’s website.

None of the experts interviewed reported any relevant conflicts of interest. The Reagan-Udall Foundation has received sponsorships from Johnson & Johnson and AstraZeneca and has had a safety surveillance contract with Pfizer.

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Success in achondroplasia spurs testing vosoritide in more growth disorders

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Mon, 03/22/2021 - 13:31

On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.

After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.

Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.

Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.

The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.

Over the 1-year study period, the median growth velocity for those treated with vosoritide increased from about 4 cm per year to 6 cm per year. Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
 

After crossover, placebo patients catch up

In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).

“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.

Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.

“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.

Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.

“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
 

 

 

Injection site reactions most common adverse event

In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).

Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.

Based on the benefits observed in achondroplasia, other applications are now being explored.

“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.

As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.

Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.

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On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.

After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.

Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.

Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.

The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.

Over the 1-year study period, the median growth velocity for those treated with vosoritide increased from about 4 cm per year to 6 cm per year. Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
 

After crossover, placebo patients catch up

In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).

“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.

Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.

“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.

Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.

“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
 

 

 

Injection site reactions most common adverse event

In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).

Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.

Based on the benefits observed in achondroplasia, other applications are now being explored.

“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.

As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.

Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.

On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.

After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.

Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.

Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.

The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.

Over the 1-year study period, the median growth velocity for those treated with vosoritide increased from about 4 cm per year to 6 cm per year. Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
 

After crossover, placebo patients catch up

In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).

“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.

Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.

“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.

Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.

“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
 

 

 

Injection site reactions most common adverse event

In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).

Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.

Based on the benefits observed in achondroplasia, other applications are now being explored.

“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.

As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.

Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.

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2021 match sets records: Who matched and who didn’t?

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The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatiguecanceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

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

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The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatiguecanceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

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

The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatiguecanceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

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

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High obesity rates in Southern states magnify COVID threats

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In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Applying lessons from Oprah to your practice

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Wed, 03/24/2021 - 10:25

In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Dr. Jeffrey Benabio

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.



1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”



5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

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

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In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Dr. Jeffrey Benabio

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.



1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”



5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

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

In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Dr. Jeffrey Benabio

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.



1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”



5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

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

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Office etiquette: Answering patient phone calls

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Thu, 03/18/2021 - 11:47

In my office, one of the many consequences of the COVID-19 pandemic has been a dramatic increase in telephone traffic. I’m sure there are multiple reasons for this, but a major one is calls from patients who remain reluctant to visit our office in person.

Dr. Joseph S. Eastern

Our veteran front-office staff members were adept at handling phone traffic at any level, but most of them retired because of the pandemic. The young folks who replaced them have struggled at times. You would think that millennials, who spend so much time on phones, would have little to learn in that department – until you remember that Twitter, Twitch, and TikTok do not demand polished interpersonal skills.

To address this issue, I have a memo in my office, which I have written, that establishes clear rules for proper professional telephone etiquette. If you want to adapt it for your own office, feel free to do so:

1. You only have one chance to make a first impression. Even now, in the era of texting and email, the telephone remains our primary point of contact with new and long-time patients. The way we answer it determines, to a significant extent, how the community thinks of us, as people and as health care providers.

2. Answer all incoming calls before the third ring.

3. Answer warmly, enthusiastically, and professionally. Since the caller cannot see you, your voice is the only impression of our office a first-time caller will get.

4. Identify yourself and our office immediately. “Good morning, Doctor Eastern’s office. This is _____. How may I help you?” No one should ever have to ask what office they have reached, or to whom they are speaking.

5. Speak softly. This is to ensure confidentiality (more on that next), and because most people find loud telephone voices unpleasant.

6. Maintaining patient confidentiality is a top priority. It makes patients feel secure about being treated in our office, and it is also the law. Keep in mind that patients and others in the office may be able to overhear your phone conversations. Keep your voice down; never use the phone’s hands-free “speaker” function.



Be cautious about all information that is given over the phone. Don’t disclose any personal information unless you are absolutely certain you are talking to the correct patient. If the caller is not the patient, never discuss personal information without the patient’s permission.

7. Adopt a positive vocabulary – one that focuses on helping people. For example, rather than saying, “I don’t know,” say, “Let me find out for you,” or “I’ll find out who can help you with that.”

8. Offer to take a message if the caller has a question or issue you cannot address. Assure the patient that the appropriate staffer will call back later that day. That way, office workflow is not interrupted, and the patient still receives a prompt (and correct) answer.

9. All messages left overnight with the answering service must be returned as early as possible the very next business day. This is a top priority each morning. Few things annoy callers trying to reach their doctors more than unreturned calls. If the office will be closed for a holiday, or a response will be delayed for any other reason, make sure the service knows, and passes it on to patients.

10. Everyone in the office must answer calls when necessary. If you notice that a phone is ringing and the receptionists are swamped, please answer it; an incoming call must never go unanswered.

11. If the phone rings while you are dealing with a patient in person, the patient in front of you is your first priority. Put the caller on hold, but always ask permission before doing so, and wait for an answer. Never leave a caller on hold for more than a minute or two unless absolutely unavoidable.

12. NEVER answer, “Doctor’s office, please hold.” To a patient, that is even worse than not answering at all. No matter how often your hold message tells callers how important they are, they know they are being ignored. Such encounters never end well: Those who wait will be grumpy and rude when you get back to them; those who hang up will be even more grumpy and rude when they call back. Worst of all are those who don’t call back and seek care elsewhere – often leaving a nasty comment on social media besides.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

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In my office, one of the many consequences of the COVID-19 pandemic has been a dramatic increase in telephone traffic. I’m sure there are multiple reasons for this, but a major one is calls from patients who remain reluctant to visit our office in person.

Dr. Joseph S. Eastern

Our veteran front-office staff members were adept at handling phone traffic at any level, but most of them retired because of the pandemic. The young folks who replaced them have struggled at times. You would think that millennials, who spend so much time on phones, would have little to learn in that department – until you remember that Twitter, Twitch, and TikTok do not demand polished interpersonal skills.

To address this issue, I have a memo in my office, which I have written, that establishes clear rules for proper professional telephone etiquette. If you want to adapt it for your own office, feel free to do so:

1. You only have one chance to make a first impression. Even now, in the era of texting and email, the telephone remains our primary point of contact with new and long-time patients. The way we answer it determines, to a significant extent, how the community thinks of us, as people and as health care providers.

2. Answer all incoming calls before the third ring.

3. Answer warmly, enthusiastically, and professionally. Since the caller cannot see you, your voice is the only impression of our office a first-time caller will get.

4. Identify yourself and our office immediately. “Good morning, Doctor Eastern’s office. This is _____. How may I help you?” No one should ever have to ask what office they have reached, or to whom they are speaking.

5. Speak softly. This is to ensure confidentiality (more on that next), and because most people find loud telephone voices unpleasant.

6. Maintaining patient confidentiality is a top priority. It makes patients feel secure about being treated in our office, and it is also the law. Keep in mind that patients and others in the office may be able to overhear your phone conversations. Keep your voice down; never use the phone’s hands-free “speaker” function.



Be cautious about all information that is given over the phone. Don’t disclose any personal information unless you are absolutely certain you are talking to the correct patient. If the caller is not the patient, never discuss personal information without the patient’s permission.

7. Adopt a positive vocabulary – one that focuses on helping people. For example, rather than saying, “I don’t know,” say, “Let me find out for you,” or “I’ll find out who can help you with that.”

8. Offer to take a message if the caller has a question or issue you cannot address. Assure the patient that the appropriate staffer will call back later that day. That way, office workflow is not interrupted, and the patient still receives a prompt (and correct) answer.

9. All messages left overnight with the answering service must be returned as early as possible the very next business day. This is a top priority each morning. Few things annoy callers trying to reach their doctors more than unreturned calls. If the office will be closed for a holiday, or a response will be delayed for any other reason, make sure the service knows, and passes it on to patients.

10. Everyone in the office must answer calls when necessary. If you notice that a phone is ringing and the receptionists are swamped, please answer it; an incoming call must never go unanswered.

11. If the phone rings while you are dealing with a patient in person, the patient in front of you is your first priority. Put the caller on hold, but always ask permission before doing so, and wait for an answer. Never leave a caller on hold for more than a minute or two unless absolutely unavoidable.

12. NEVER answer, “Doctor’s office, please hold.” To a patient, that is even worse than not answering at all. No matter how often your hold message tells callers how important they are, they know they are being ignored. Such encounters never end well: Those who wait will be grumpy and rude when you get back to them; those who hang up will be even more grumpy and rude when they call back. Worst of all are those who don’t call back and seek care elsewhere – often leaving a nasty comment on social media besides.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

In my office, one of the many consequences of the COVID-19 pandemic has been a dramatic increase in telephone traffic. I’m sure there are multiple reasons for this, but a major one is calls from patients who remain reluctant to visit our office in person.

Dr. Joseph S. Eastern

Our veteran front-office staff members were adept at handling phone traffic at any level, but most of them retired because of the pandemic. The young folks who replaced them have struggled at times. You would think that millennials, who spend so much time on phones, would have little to learn in that department – until you remember that Twitter, Twitch, and TikTok do not demand polished interpersonal skills.

To address this issue, I have a memo in my office, which I have written, that establishes clear rules for proper professional telephone etiquette. If you want to adapt it for your own office, feel free to do so:

1. You only have one chance to make a first impression. Even now, in the era of texting and email, the telephone remains our primary point of contact with new and long-time patients. The way we answer it determines, to a significant extent, how the community thinks of us, as people and as health care providers.

2. Answer all incoming calls before the third ring.

3. Answer warmly, enthusiastically, and professionally. Since the caller cannot see you, your voice is the only impression of our office a first-time caller will get.

4. Identify yourself and our office immediately. “Good morning, Doctor Eastern’s office. This is _____. How may I help you?” No one should ever have to ask what office they have reached, or to whom they are speaking.

5. Speak softly. This is to ensure confidentiality (more on that next), and because most people find loud telephone voices unpleasant.

6. Maintaining patient confidentiality is a top priority. It makes patients feel secure about being treated in our office, and it is also the law. Keep in mind that patients and others in the office may be able to overhear your phone conversations. Keep your voice down; never use the phone’s hands-free “speaker” function.



Be cautious about all information that is given over the phone. Don’t disclose any personal information unless you are absolutely certain you are talking to the correct patient. If the caller is not the patient, never discuss personal information without the patient’s permission.

7. Adopt a positive vocabulary – one that focuses on helping people. For example, rather than saying, “I don’t know,” say, “Let me find out for you,” or “I’ll find out who can help you with that.”

8. Offer to take a message if the caller has a question or issue you cannot address. Assure the patient that the appropriate staffer will call back later that day. That way, office workflow is not interrupted, and the patient still receives a prompt (and correct) answer.

9. All messages left overnight with the answering service must be returned as early as possible the very next business day. This is a top priority each morning. Few things annoy callers trying to reach their doctors more than unreturned calls. If the office will be closed for a holiday, or a response will be delayed for any other reason, make sure the service knows, and passes it on to patients.

10. Everyone in the office must answer calls when necessary. If you notice that a phone is ringing and the receptionists are swamped, please answer it; an incoming call must never go unanswered.

11. If the phone rings while you are dealing with a patient in person, the patient in front of you is your first priority. Put the caller on hold, but always ask permission before doing so, and wait for an answer. Never leave a caller on hold for more than a minute or two unless absolutely unavoidable.

12. NEVER answer, “Doctor’s office, please hold.” To a patient, that is even worse than not answering at all. No matter how often your hold message tells callers how important they are, they know they are being ignored. Such encounters never end well: Those who wait will be grumpy and rude when you get back to them; those who hang up will be even more grumpy and rude when they call back. Worst of all are those who don’t call back and seek care elsewhere – often leaving a nasty comment on social media besides.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

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Some with long COVID see relief after vaccination

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Several weeks after getting his second dose of an mRNA vaccine, Aaron Goyang thinks his long bout with COVID-19 has finally come to an end.

Geber86/Getty Images

Mr. Goyang, who is 33 and is a radiology technician in Austin, Tex., thinks he got COVID-19 from some of the coughing, gasping patients he treated last spring.

At the time, testing was scarce, and by the time he was tested – several weeks into his illness – it came back negative. He fought off the initial symptoms but experienced relapse a week later.

Mr. Goyang says that, for the next 8 or 9 months, he was on a roller coaster with extreme shortness of breath and chest tightness that could be so severe it would send him to the emergency department. He had to use an inhaler to get through his workdays.

“Even if I was just sitting around, it would come and take me,” he says. “It almost felt like someone was bear-hugging me constantly, and I just couldn’t get in a good enough breath.”

On his best days, he would walk around his neighborhood, being careful not to overdo it. He tried running once, and it nearly sent him to the hospital.

“Very honestly, I didn’t know if I would ever be able to do it again,” he says.

But Mr. Goyang says that, several weeks after getting the Pfizer vaccine, he was able to run a mile again with no problems. “I was very thankful for that,” he says.

Mr. Goyang is not alone. Some social media groups are dedicated to patients who are living with a condition that’s been known as long COVID and that was recently termed postacute sequelae of SARS-CoV-2 infection (PASC). These patients are sometimes referred to as long haulers.

On social media, patients with PASC are eagerly and anxiously quizzing each other about the vaccines and their effects. Some report that they’ve finally seen their symptoms resolve, giving hope that long COVID might not be a lifelong condition.

Survivor Corps, which has a public Facebook group with 159,000 members, recently took a poll to see whether there was any substance to rumors that those with long COVID were feeling better after being vaccinated.

“Out of 400 people, 36% showed an improvement in symptoms, anywhere between a mild improvement to complete resolution of symptoms,” said Diana Berrent, a long-COVID patient who founded the group. Survivor Corps has become active in patient advocacy and is a resource for researchers studying the new condition.

Ms. Berrent has become such a trusted voice during the pandemic. She interviewed Anthony Fauci, MD, head of the National Institutes of Allergy and Infectious Diseases, last October.

“The implications are huge,” she says.

“Some of this damage is permanent damage. It’s not going to cure the scarring of your heart tissue, it’s not going to cure the irreparable damage to your lungs, but if it’s making people feel better, then that’s an indication there’s viral persistence going on,” says Ms. Berrent.

“I’ve been saying for months and months, we shouldn’t be calling this postacute anything,” she adds.
 

 

 

Patients report improvement

Daniel Griffin, MD, PhD, is equally excited. He’s an infectious disease specialist at Columbia University, New York. He says about one in five patients he treated for COVID-19 last year never got better. Many of them, such as Mr. Goyang, were health care workers.

“I don’t know if people actually catch this, but a lot of our coworkers are either permanently disabled or died,” Dr. Griffin says.

Health care workers were also among the first to be vaccinated. Dr. Griffin says many of his patients began reaching out to him about a week or two after being vaccinated “and saying, ‘You know, I actually feel better.’ And some of them were saying, ‘I feel all better,’ after being sick – a lot of them – for a year.”

Then he was getting calls and texts from other doctors, asking, “Hey, are you seeing this?”

The benefits of vaccination for some long-haulers came as a surprise. Dr. Griffin says that, before the vaccines came out, many of his patients were worried that getting vaccinated might overstimulate their immune systems and cause symptoms to get worse.

Indeed, a small percentage of people – about 3%-5%, based on informal polls on social media – report that they do experience worsening of symptoms after getting the shot. It’s not clear why.

Dr. Griffin estimates that between 30% and 50% of patients’ symptoms improve after they receive the mRNA vaccines. “I’m seeing this chunk of people – they tell me their brain fog has improved, their fatigue is gone, the fevers that wouldn’t resolve have now gone,” he says. “I’m seeing that personally, and I’m hearing it from my colleagues.”

Dr. Griffin says the observation has launched several studies and that there are several theories about how the vaccines might be affecting long COVID.
 

An immune system boost?

One possibility is that the virus continues to stimulate the immune system, which continues to fight the virus for months. If that is the case, Dr. Griffin says, the vaccine may be giving the immune system the boost it needs to finally clear the virus away.

Donna Farber, PhD, a professor of microbiology and immunology at Columbia University, has heard the stories, too.

“It is possible that the persisting virus in long COVID-19 may be at a low level – not enough to stimulate a potent immune response to clear the virus, but enough to cause symptoms. Activating the immune response therefore is therapeutic in directing viral clearance,” she says.

Dr. Farber explains that long COVID may be a bit like Lyme disease. Some patients with Lyme disease must take antibiotics for months before their symptoms disappear.

Dr. Griffin says there’s another possibility. Several studies have now shown that people with lingering COVID-19 symptoms develop autoantibodies. There’s a theory that SARS-CoV-2 may create an autoimmune condition that leads to long-term symptoms.

If that is the case, Dr. Griffin says, the vaccine may be helping the body to reset its tolerance to itself, “so maybe now you’re getting a healthy immune response.”

More studies are needed to know for sure.

Either way, the vaccines are a much-needed bit of hope for the long-COVID community, and Dr. Griffin tells his patients who are still worried that, at the very least, they’ll be protected from another SARS-CoV-2 infection.

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

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Several weeks after getting his second dose of an mRNA vaccine, Aaron Goyang thinks his long bout with COVID-19 has finally come to an end.

Geber86/Getty Images

Mr. Goyang, who is 33 and is a radiology technician in Austin, Tex., thinks he got COVID-19 from some of the coughing, gasping patients he treated last spring.

At the time, testing was scarce, and by the time he was tested – several weeks into his illness – it came back negative. He fought off the initial symptoms but experienced relapse a week later.

Mr. Goyang says that, for the next 8 or 9 months, he was on a roller coaster with extreme shortness of breath and chest tightness that could be so severe it would send him to the emergency department. He had to use an inhaler to get through his workdays.

“Even if I was just sitting around, it would come and take me,” he says. “It almost felt like someone was bear-hugging me constantly, and I just couldn’t get in a good enough breath.”

On his best days, he would walk around his neighborhood, being careful not to overdo it. He tried running once, and it nearly sent him to the hospital.

“Very honestly, I didn’t know if I would ever be able to do it again,” he says.

But Mr. Goyang says that, several weeks after getting the Pfizer vaccine, he was able to run a mile again with no problems. “I was very thankful for that,” he says.

Mr. Goyang is not alone. Some social media groups are dedicated to patients who are living with a condition that’s been known as long COVID and that was recently termed postacute sequelae of SARS-CoV-2 infection (PASC). These patients are sometimes referred to as long haulers.

On social media, patients with PASC are eagerly and anxiously quizzing each other about the vaccines and their effects. Some report that they’ve finally seen their symptoms resolve, giving hope that long COVID might not be a lifelong condition.

Survivor Corps, which has a public Facebook group with 159,000 members, recently took a poll to see whether there was any substance to rumors that those with long COVID were feeling better after being vaccinated.

“Out of 400 people, 36% showed an improvement in symptoms, anywhere between a mild improvement to complete resolution of symptoms,” said Diana Berrent, a long-COVID patient who founded the group. Survivor Corps has become active in patient advocacy and is a resource for researchers studying the new condition.

Ms. Berrent has become such a trusted voice during the pandemic. She interviewed Anthony Fauci, MD, head of the National Institutes of Allergy and Infectious Diseases, last October.

“The implications are huge,” she says.

“Some of this damage is permanent damage. It’s not going to cure the scarring of your heart tissue, it’s not going to cure the irreparable damage to your lungs, but if it’s making people feel better, then that’s an indication there’s viral persistence going on,” says Ms. Berrent.

“I’ve been saying for months and months, we shouldn’t be calling this postacute anything,” she adds.
 

 

 

Patients report improvement

Daniel Griffin, MD, PhD, is equally excited. He’s an infectious disease specialist at Columbia University, New York. He says about one in five patients he treated for COVID-19 last year never got better. Many of them, such as Mr. Goyang, were health care workers.

“I don’t know if people actually catch this, but a lot of our coworkers are either permanently disabled or died,” Dr. Griffin says.

Health care workers were also among the first to be vaccinated. Dr. Griffin says many of his patients began reaching out to him about a week or two after being vaccinated “and saying, ‘You know, I actually feel better.’ And some of them were saying, ‘I feel all better,’ after being sick – a lot of them – for a year.”

Then he was getting calls and texts from other doctors, asking, “Hey, are you seeing this?”

The benefits of vaccination for some long-haulers came as a surprise. Dr. Griffin says that, before the vaccines came out, many of his patients were worried that getting vaccinated might overstimulate their immune systems and cause symptoms to get worse.

Indeed, a small percentage of people – about 3%-5%, based on informal polls on social media – report that they do experience worsening of symptoms after getting the shot. It’s not clear why.

Dr. Griffin estimates that between 30% and 50% of patients’ symptoms improve after they receive the mRNA vaccines. “I’m seeing this chunk of people – they tell me their brain fog has improved, their fatigue is gone, the fevers that wouldn’t resolve have now gone,” he says. “I’m seeing that personally, and I’m hearing it from my colleagues.”

Dr. Griffin says the observation has launched several studies and that there are several theories about how the vaccines might be affecting long COVID.
 

An immune system boost?

One possibility is that the virus continues to stimulate the immune system, which continues to fight the virus for months. If that is the case, Dr. Griffin says, the vaccine may be giving the immune system the boost it needs to finally clear the virus away.

Donna Farber, PhD, a professor of microbiology and immunology at Columbia University, has heard the stories, too.

“It is possible that the persisting virus in long COVID-19 may be at a low level – not enough to stimulate a potent immune response to clear the virus, but enough to cause symptoms. Activating the immune response therefore is therapeutic in directing viral clearance,” she says.

Dr. Farber explains that long COVID may be a bit like Lyme disease. Some patients with Lyme disease must take antibiotics for months before their symptoms disappear.

Dr. Griffin says there’s another possibility. Several studies have now shown that people with lingering COVID-19 symptoms develop autoantibodies. There’s a theory that SARS-CoV-2 may create an autoimmune condition that leads to long-term symptoms.

If that is the case, Dr. Griffin says, the vaccine may be helping the body to reset its tolerance to itself, “so maybe now you’re getting a healthy immune response.”

More studies are needed to know for sure.

Either way, the vaccines are a much-needed bit of hope for the long-COVID community, and Dr. Griffin tells his patients who are still worried that, at the very least, they’ll be protected from another SARS-CoV-2 infection.

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

Several weeks after getting his second dose of an mRNA vaccine, Aaron Goyang thinks his long bout with COVID-19 has finally come to an end.

Geber86/Getty Images

Mr. Goyang, who is 33 and is a radiology technician in Austin, Tex., thinks he got COVID-19 from some of the coughing, gasping patients he treated last spring.

At the time, testing was scarce, and by the time he was tested – several weeks into his illness – it came back negative. He fought off the initial symptoms but experienced relapse a week later.

Mr. Goyang says that, for the next 8 or 9 months, he was on a roller coaster with extreme shortness of breath and chest tightness that could be so severe it would send him to the emergency department. He had to use an inhaler to get through his workdays.

“Even if I was just sitting around, it would come and take me,” he says. “It almost felt like someone was bear-hugging me constantly, and I just couldn’t get in a good enough breath.”

On his best days, he would walk around his neighborhood, being careful not to overdo it. He tried running once, and it nearly sent him to the hospital.

“Very honestly, I didn’t know if I would ever be able to do it again,” he says.

But Mr. Goyang says that, several weeks after getting the Pfizer vaccine, he was able to run a mile again with no problems. “I was very thankful for that,” he says.

Mr. Goyang is not alone. Some social media groups are dedicated to patients who are living with a condition that’s been known as long COVID and that was recently termed postacute sequelae of SARS-CoV-2 infection (PASC). These patients are sometimes referred to as long haulers.

On social media, patients with PASC are eagerly and anxiously quizzing each other about the vaccines and their effects. Some report that they’ve finally seen their symptoms resolve, giving hope that long COVID might not be a lifelong condition.

Survivor Corps, which has a public Facebook group with 159,000 members, recently took a poll to see whether there was any substance to rumors that those with long COVID were feeling better after being vaccinated.

“Out of 400 people, 36% showed an improvement in symptoms, anywhere between a mild improvement to complete resolution of symptoms,” said Diana Berrent, a long-COVID patient who founded the group. Survivor Corps has become active in patient advocacy and is a resource for researchers studying the new condition.

Ms. Berrent has become such a trusted voice during the pandemic. She interviewed Anthony Fauci, MD, head of the National Institutes of Allergy and Infectious Diseases, last October.

“The implications are huge,” she says.

“Some of this damage is permanent damage. It’s not going to cure the scarring of your heart tissue, it’s not going to cure the irreparable damage to your lungs, but if it’s making people feel better, then that’s an indication there’s viral persistence going on,” says Ms. Berrent.

“I’ve been saying for months and months, we shouldn’t be calling this postacute anything,” she adds.
 

 

 

Patients report improvement

Daniel Griffin, MD, PhD, is equally excited. He’s an infectious disease specialist at Columbia University, New York. He says about one in five patients he treated for COVID-19 last year never got better. Many of them, such as Mr. Goyang, were health care workers.

“I don’t know if people actually catch this, but a lot of our coworkers are either permanently disabled or died,” Dr. Griffin says.

Health care workers were also among the first to be vaccinated. Dr. Griffin says many of his patients began reaching out to him about a week or two after being vaccinated “and saying, ‘You know, I actually feel better.’ And some of them were saying, ‘I feel all better,’ after being sick – a lot of them – for a year.”

Then he was getting calls and texts from other doctors, asking, “Hey, are you seeing this?”

The benefits of vaccination for some long-haulers came as a surprise. Dr. Griffin says that, before the vaccines came out, many of his patients were worried that getting vaccinated might overstimulate their immune systems and cause symptoms to get worse.

Indeed, a small percentage of people – about 3%-5%, based on informal polls on social media – report that they do experience worsening of symptoms after getting the shot. It’s not clear why.

Dr. Griffin estimates that between 30% and 50% of patients’ symptoms improve after they receive the mRNA vaccines. “I’m seeing this chunk of people – they tell me their brain fog has improved, their fatigue is gone, the fevers that wouldn’t resolve have now gone,” he says. “I’m seeing that personally, and I’m hearing it from my colleagues.”

Dr. Griffin says the observation has launched several studies and that there are several theories about how the vaccines might be affecting long COVID.
 

An immune system boost?

One possibility is that the virus continues to stimulate the immune system, which continues to fight the virus for months. If that is the case, Dr. Griffin says, the vaccine may be giving the immune system the boost it needs to finally clear the virus away.

Donna Farber, PhD, a professor of microbiology and immunology at Columbia University, has heard the stories, too.

“It is possible that the persisting virus in long COVID-19 may be at a low level – not enough to stimulate a potent immune response to clear the virus, but enough to cause symptoms. Activating the immune response therefore is therapeutic in directing viral clearance,” she says.

Dr. Farber explains that long COVID may be a bit like Lyme disease. Some patients with Lyme disease must take antibiotics for months before their symptoms disappear.

Dr. Griffin says there’s another possibility. Several studies have now shown that people with lingering COVID-19 symptoms develop autoantibodies. There’s a theory that SARS-CoV-2 may create an autoimmune condition that leads to long-term symptoms.

If that is the case, Dr. Griffin says, the vaccine may be helping the body to reset its tolerance to itself, “so maybe now you’re getting a healthy immune response.”

More studies are needed to know for sure.

Either way, the vaccines are a much-needed bit of hope for the long-COVID community, and Dr. Griffin tells his patients who are still worried that, at the very least, they’ll be protected from another SARS-CoV-2 infection.

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

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We’re all vaccinated: Can we go back to the office (unmasked) now?

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Thu, 08/26/2021 - 15:49

Congratulations, you’ve been vaccinated!

It’s been a year like no other, and outpatient psychiatrists turned to Zoom and other telemental health platforms to provide treatment for our patients. Offices sit empty as the dust lands and the plants wilt. Perhaps a few patients are seen in person, masked and carefully distanced, after health screening and temperature checks, with surfaces sanitized between visits, all in accordance with health department regulations. But now the vaccine offers both safety and the promise of a return to a new normal, one that is certain to look different from the normal that was left behind.

Courtesy CDC


I have been vaccinated and many of my patients have also been vaccinated. I began to wonder if it was safe to start seeing patients in person; could I see fully vaccinated patients, unmasked and without temperature checks and sanitizing? I started asking this question in February, and the response I got then was that it was too soon to tell; we did not have any data on whether vaccinated people could transmit the novel coronavirus. Two vaccinated people might be at risk of transmitting the virus and then infecting others, and the question of whether the vaccines would protect against illness caused by variants remained. Preliminary data out of Israel indicated that the vaccine did reduce transmission, but no one was saying that it was fine to see patients without masks, and video-conferencing remained the safest option.

Dr. Dinah Miller


On Monday, March 8, 2021, the Centers for Disease Control and Prevention released long-awaited interim public health guidelines for fully vaccinated people. The guidelines allowed for two vaccinated people to be in a room together unmasked, and for a fully-vaccinated person to be in a room unmasked with an unvaccinated person who did not have risk factors for becoming severely ill with COVID. Was this the green light that psychiatrists were waiting for? Was there new data about transmission, or was this part of the CDC’s effort to make vaccines more desirable?

Michael Chang, MD, is a pediatric infectious disease specialist at the University of Texas Health Science Center at Houston. We spoke 2 days after the CDC interim guidelines were released. Dr. Chang was optimistic.

There is no zero-risk way of seeing patients in person and there is still a lot we don’t know, including data about variants and about transmission. At some point, however, the risk is low enough, and we should probably start thinking about going back to in-person visits,” Dr. Chang said. He said he personally would feel safe meeting unmasked with a vaccinated patient, but noted that his institution still requires doctors to wear masks. “Most vaccinations reduce transmission of illness,” Dr. Chang said, “but SARS-CoV-2 continues to surprise us in many ways.”

Katelyn Jetelina, PhD, MPH, an epidemiologist at the University of Texas School of Public Health in Dallas, distributes a newsletter, “Your Local Epidemiologist,” where she discusses data pertaining to the pandemic. In her newsletter dated March 14, 2021, Dr. Jetelina wrote, “There are now 7 sub-studies/press releases that confirm a 50-95% reduced transmission after vaccination. This is a big range, which is typical for such drastically different scientific studies. Variability is likely due to different sample sizes, locations, vaccines, genetics, cultures, etc. It will be a while until we know the ‘true’ percentage for each vaccine.”

Leslie Walker, MD, is a fully vaccinated psychiatrist in private practice in Shaker Heights, Ohio. She has recently started seeing fully vaccinated patients in person.

“So far it’s only 1 or 2 patients a day. I’m leaving it up to the patient. If they prefer masks, we stay masked. I may reverse course, depending on what information comes out.” She went on to note, “There are benefits to being able to see someone’s full facial expressions and whether they match someone’s words and body language, so the benefit of “unmasking” extends beyond comfort and convenience and must be balanced against the theoretical risk of COVID exposure in the room.”

While the CDC has now said it is safe to meet, the state health departments also have guidelines for medical practices, and everyone is still worried about vulnerable people in their households and potential spread to the community at large.

In Maryland, where I work, Aliya Jones, MD, MBA, is the head of the Behavioral Health Administration (BHA) for the Maryland Department of Health. “It remains risky to not wear masks, however, the risk is low when both individuals are vaccinated,” Dr. Jones wrote. “BHA is not recommending that providers see clients without both parties wearing a mask. All of our general practice recommendations for infection control are unchanged. People should be screened before entering clinical practices and persons who are symptomatic, whether vaccinated or not, should not be seen face-to-face, except in cases of an emergency, in which case additional precautions should be taken.”

So is it safe for a fully-vaccinated psychiatrist to have a session with a fully-vaccinated patient sitting 8 feet apart without masks? I’m left with the idea that it is for those two people, but when it comes to unvaccinated people in their households, we want more certainty than we currently have. The messaging remains unclear. The CDC’s interim guidelines offer hope for a future, but the science is still catching up, and to feel safe enough, we may want to wait a little longer for more definitive data – or herd immunity – before we reveal our smiles.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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Congratulations, you’ve been vaccinated!

It’s been a year like no other, and outpatient psychiatrists turned to Zoom and other telemental health platforms to provide treatment for our patients. Offices sit empty as the dust lands and the plants wilt. Perhaps a few patients are seen in person, masked and carefully distanced, after health screening and temperature checks, with surfaces sanitized between visits, all in accordance with health department regulations. But now the vaccine offers both safety and the promise of a return to a new normal, one that is certain to look different from the normal that was left behind.

Courtesy CDC


I have been vaccinated and many of my patients have also been vaccinated. I began to wonder if it was safe to start seeing patients in person; could I see fully vaccinated patients, unmasked and without temperature checks and sanitizing? I started asking this question in February, and the response I got then was that it was too soon to tell; we did not have any data on whether vaccinated people could transmit the novel coronavirus. Two vaccinated people might be at risk of transmitting the virus and then infecting others, and the question of whether the vaccines would protect against illness caused by variants remained. Preliminary data out of Israel indicated that the vaccine did reduce transmission, but no one was saying that it was fine to see patients without masks, and video-conferencing remained the safest option.

Dr. Dinah Miller


On Monday, March 8, 2021, the Centers for Disease Control and Prevention released long-awaited interim public health guidelines for fully vaccinated people. The guidelines allowed for two vaccinated people to be in a room together unmasked, and for a fully-vaccinated person to be in a room unmasked with an unvaccinated person who did not have risk factors for becoming severely ill with COVID. Was this the green light that psychiatrists were waiting for? Was there new data about transmission, or was this part of the CDC’s effort to make vaccines more desirable?

Michael Chang, MD, is a pediatric infectious disease specialist at the University of Texas Health Science Center at Houston. We spoke 2 days after the CDC interim guidelines were released. Dr. Chang was optimistic.

There is no zero-risk way of seeing patients in person and there is still a lot we don’t know, including data about variants and about transmission. At some point, however, the risk is low enough, and we should probably start thinking about going back to in-person visits,” Dr. Chang said. He said he personally would feel safe meeting unmasked with a vaccinated patient, but noted that his institution still requires doctors to wear masks. “Most vaccinations reduce transmission of illness,” Dr. Chang said, “but SARS-CoV-2 continues to surprise us in many ways.”

Katelyn Jetelina, PhD, MPH, an epidemiologist at the University of Texas School of Public Health in Dallas, distributes a newsletter, “Your Local Epidemiologist,” where she discusses data pertaining to the pandemic. In her newsletter dated March 14, 2021, Dr. Jetelina wrote, “There are now 7 sub-studies/press releases that confirm a 50-95% reduced transmission after vaccination. This is a big range, which is typical for such drastically different scientific studies. Variability is likely due to different sample sizes, locations, vaccines, genetics, cultures, etc. It will be a while until we know the ‘true’ percentage for each vaccine.”

Leslie Walker, MD, is a fully vaccinated psychiatrist in private practice in Shaker Heights, Ohio. She has recently started seeing fully vaccinated patients in person.

“So far it’s only 1 or 2 patients a day. I’m leaving it up to the patient. If they prefer masks, we stay masked. I may reverse course, depending on what information comes out.” She went on to note, “There are benefits to being able to see someone’s full facial expressions and whether they match someone’s words and body language, so the benefit of “unmasking” extends beyond comfort and convenience and must be balanced against the theoretical risk of COVID exposure in the room.”

While the CDC has now said it is safe to meet, the state health departments also have guidelines for medical practices, and everyone is still worried about vulnerable people in their households and potential spread to the community at large.

In Maryland, where I work, Aliya Jones, MD, MBA, is the head of the Behavioral Health Administration (BHA) for the Maryland Department of Health. “It remains risky to not wear masks, however, the risk is low when both individuals are vaccinated,” Dr. Jones wrote. “BHA is not recommending that providers see clients without both parties wearing a mask. All of our general practice recommendations for infection control are unchanged. People should be screened before entering clinical practices and persons who are symptomatic, whether vaccinated or not, should not be seen face-to-face, except in cases of an emergency, in which case additional precautions should be taken.”

So is it safe for a fully-vaccinated psychiatrist to have a session with a fully-vaccinated patient sitting 8 feet apart without masks? I’m left with the idea that it is for those two people, but when it comes to unvaccinated people in their households, we want more certainty than we currently have. The messaging remains unclear. The CDC’s interim guidelines offer hope for a future, but the science is still catching up, and to feel safe enough, we may want to wait a little longer for more definitive data – or herd immunity – before we reveal our smiles.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Congratulations, you’ve been vaccinated!

It’s been a year like no other, and outpatient psychiatrists turned to Zoom and other telemental health platforms to provide treatment for our patients. Offices sit empty as the dust lands and the plants wilt. Perhaps a few patients are seen in person, masked and carefully distanced, after health screening and temperature checks, with surfaces sanitized between visits, all in accordance with health department regulations. But now the vaccine offers both safety and the promise of a return to a new normal, one that is certain to look different from the normal that was left behind.

Courtesy CDC


I have been vaccinated and many of my patients have also been vaccinated. I began to wonder if it was safe to start seeing patients in person; could I see fully vaccinated patients, unmasked and without temperature checks and sanitizing? I started asking this question in February, and the response I got then was that it was too soon to tell; we did not have any data on whether vaccinated people could transmit the novel coronavirus. Two vaccinated people might be at risk of transmitting the virus and then infecting others, and the question of whether the vaccines would protect against illness caused by variants remained. Preliminary data out of Israel indicated that the vaccine did reduce transmission, but no one was saying that it was fine to see patients without masks, and video-conferencing remained the safest option.

Dr. Dinah Miller


On Monday, March 8, 2021, the Centers for Disease Control and Prevention released long-awaited interim public health guidelines for fully vaccinated people. The guidelines allowed for two vaccinated people to be in a room together unmasked, and for a fully-vaccinated person to be in a room unmasked with an unvaccinated person who did not have risk factors for becoming severely ill with COVID. Was this the green light that psychiatrists were waiting for? Was there new data about transmission, or was this part of the CDC’s effort to make vaccines more desirable?

Michael Chang, MD, is a pediatric infectious disease specialist at the University of Texas Health Science Center at Houston. We spoke 2 days after the CDC interim guidelines were released. Dr. Chang was optimistic.

There is no zero-risk way of seeing patients in person and there is still a lot we don’t know, including data about variants and about transmission. At some point, however, the risk is low enough, and we should probably start thinking about going back to in-person visits,” Dr. Chang said. He said he personally would feel safe meeting unmasked with a vaccinated patient, but noted that his institution still requires doctors to wear masks. “Most vaccinations reduce transmission of illness,” Dr. Chang said, “but SARS-CoV-2 continues to surprise us in many ways.”

Katelyn Jetelina, PhD, MPH, an epidemiologist at the University of Texas School of Public Health in Dallas, distributes a newsletter, “Your Local Epidemiologist,” where she discusses data pertaining to the pandemic. In her newsletter dated March 14, 2021, Dr. Jetelina wrote, “There are now 7 sub-studies/press releases that confirm a 50-95% reduced transmission after vaccination. This is a big range, which is typical for such drastically different scientific studies. Variability is likely due to different sample sizes, locations, vaccines, genetics, cultures, etc. It will be a while until we know the ‘true’ percentage for each vaccine.”

Leslie Walker, MD, is a fully vaccinated psychiatrist in private practice in Shaker Heights, Ohio. She has recently started seeing fully vaccinated patients in person.

“So far it’s only 1 or 2 patients a day. I’m leaving it up to the patient. If they prefer masks, we stay masked. I may reverse course, depending on what information comes out.” She went on to note, “There are benefits to being able to see someone’s full facial expressions and whether they match someone’s words and body language, so the benefit of “unmasking” extends beyond comfort and convenience and must be balanced against the theoretical risk of COVID exposure in the room.”

While the CDC has now said it is safe to meet, the state health departments also have guidelines for medical practices, and everyone is still worried about vulnerable people in their households and potential spread to the community at large.

In Maryland, where I work, Aliya Jones, MD, MBA, is the head of the Behavioral Health Administration (BHA) for the Maryland Department of Health. “It remains risky to not wear masks, however, the risk is low when both individuals are vaccinated,” Dr. Jones wrote. “BHA is not recommending that providers see clients without both parties wearing a mask. All of our general practice recommendations for infection control are unchanged. People should be screened before entering clinical practices and persons who are symptomatic, whether vaccinated or not, should not be seen face-to-face, except in cases of an emergency, in which case additional precautions should be taken.”

So is it safe for a fully-vaccinated psychiatrist to have a session with a fully-vaccinated patient sitting 8 feet apart without masks? I’m left with the idea that it is for those two people, but when it comes to unvaccinated people in their households, we want more certainty than we currently have. The messaging remains unclear. The CDC’s interim guidelines offer hope for a future, but the science is still catching up, and to feel safe enough, we may want to wait a little longer for more definitive data – or herd immunity – before we reveal our smiles.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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